← Back to catalogue

Luna Dental Implant System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K223395

by Shinhung MST Co., Ltd.

Identity

Trade Name
SI FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Screw endosteal dental implant, two-piece FDA UDI
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name
The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Luna Ø4.0 x 13 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø4.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abut. RP Ø5.0 The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction. FDA UDI
The healing abutment is to be connected to the implant and is to heal gingiva before setting abutment on the implant in the oral cavity. It is made of commercially pure titanium alloy Gr4. It offers narrow and regular platform types, and the narrow type has anodizing surface treatment in purple to be distinguished from the regular type. FDA UDI
The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. FDA UDI
Healing Abutment Ø4.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø5.0 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
25 Angled Abutment 4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
25 Angled Abutment 5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Luna Ø4.0 x 15 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
15 Angled Abutment 4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
15 Angled Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Model / Reference
SDAR4553H FDA UDI
SIR4013S FDA UDI
SHAR5020 FDA UDI
SDAN4551H FDA UDI
SDAR5071 FDA UDI
SHAR6070 FDA UDI
SHAR6050 FDA UDI
SIR7008SF FDA UDI
NSHAN4522 FDA UDI
SIR4508SF FDA UDI
SDAN4574H FDA UDI
SHAR4050 FDA UDI
NSHAR5534 FDA UDI
NSHAR5522 FDA UDI
NSHAR5035 FDA UDI
SDAN5052 FDA UDI
SIR4510SF FDA UDI
SIR7011SF FDA UDI
SAA4525R40H FDA UDI
SDAR4573H FDA UDI
SAA5525R20H FDA UDI
SAA5515R20HF FDA UDI
SDAR4555 FDA UDI
SHAN3535 FDA UDI
NSHAR4022 FDA UDI
SIR5010SF FDA UDI
SHAR4020 FDA UDI
SDAR5074 FDA UDI
SIR4015S FDA UDI
SAA4515R20 FDA UDI
SHAR6550 FDA UDI
SDAR4554H FDA UDI
SIR7011S FDA UDI
SHAR4550 FDA UDI
SAA5515R20H FDA UDI
NSHAN4034 FDA UDI
SDAR6043 FDA UDI
SDAR5051H FDA UDI
SIR4007S FDA UDI
SDAR5054H FDA UDI
SIR5507S FDA UDI
SHAR5050 FDA UDI
SIR5011S FDA UDI
SDAN5075 FDA UDI
SDAN4554H FDA UDI
SHAR4035 FDA UDI
SAA4525R20HF FDA UDI
SIR4008SF FDA UDI
SDAN5044H FDA UDI
SDAN5042H FDA UDI
Description
The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Luna Ø4.0 x 13 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø4.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abut. RP Ø5.0 The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction. FDA UDI
The healing abutment is to be connected to the implant and is to heal gingiva before setting abutment on the implant in the oral cavity. It is made of commercially pure titanium alloy Gr4. It offers narrow and regular platform types, and the narrow type has anodizing surface treatment in purple to be distinguished from the regular type. FDA UDI
The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. FDA UDI
Healing Abutment Ø4.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø5.0 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
25 Angled Abutment 4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
25 Angled Abutment 5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abut. RP/Luna The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Luna Ø4.0 x 15 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
15 Angled Abutment 4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø6.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Healing Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
15 Angled Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø6.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
Duo Abutment Ø5.0 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI
The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function FDA UDI

Identifiers

Primary DI / UDI-DI
08809457209279 FDA UDI
08809457200603 FDA UDI
08809457208661 FDA UDI
08809457208913 FDA UDI
08809457209521 FDA UDI
08809457208777 FDA UDI
08809457208760 FDA UDI
08809457201280 FDA UDI
08806343908162 FDA UDI
08809457201068 FDA UDI
08806343907479 FDA UDI
08809457208609 FDA UDI
08806343912770 FDA UDI
08806343912749 FDA UDI
08806343912015 FDA UDI
08809457209088 FDA UDI
08809457201075 FDA UDI
08809457201303 FDA UDI
08809457207176 FDA UDI
08806343907561 FDA UDI
08809457207220 FDA UDI
08809458319878 FDA UDI
08809457209309 FDA UDI
08809457208357 FDA UDI
08806343911872 FDA UDI
08809457201136 FDA UDI
08809457208586 FDA UDI
08809457209583 FDA UDI
08809457200610 FDA UDI
08809457207121 FDA UDI
08809457208807 FDA UDI
08809457209293 FDA UDI
08809457200870 FDA UDI
08809457208647 FDA UDI
08809457207190 FDA UDI
08806343908148 FDA UDI
08809457209668 FDA UDI
08809457209439 FDA UDI
08809457200566 FDA UDI
08809457209491 FDA UDI
08809457200740 FDA UDI
08809457208685 FDA UDI
08809457200719 FDA UDI
08806343907684 FDA UDI
08809457208975 FDA UDI
08809457208593 FDA UDI
08809458319915 FDA UDI
08809457201006 FDA UDI
08809457209057 FDA UDI
08809457209019 FDA UDI
510(k) Number
K223395 FDA 510(k)FDA UDI
K123155 FDA UDI
K160106 FDA UDI
K200189 FDA UDI
FDA Product Code
NHA FDA 510(k)FDA UDI
DZE FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI
Screw endosteal dental implant, two-piece FDA UDI
Dental implant suprastructure, temporary, preformed, single-use FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)FDA UDI
872.3640 FDA UDI
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDIFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI
MR Conditional FDA UDI

Dimensions & Sizes

Size
Height — 5.5 Millimeter FDA UDI
Outer Diameter — 4.6 Millimeter FDA UDI
Length — 11 Millimeter FDA UDI
Outer Diameter — 4.2 Millimeter FDA UDI
Length — 13 Millimeter FDA UDI
Outer Diameter — 5.5 Millimeter FDA UDI
Length — 7.97 Millimeter FDA UDI
Length — 9.1 Millimeter FDA UDI
Height — 7 Millimeter FDA UDI
Outer Diameter — 5.1 Millimeter FDA UDI
Length — 10.5 Millimeter FDA UDI
Outer Diameter — 6.5 Millimeter FDA UDI
Length — 12.97 Millimeter FDA UDI
Length — 10.97 Millimeter FDA UDI
Length — 8.5 Millimeter FDA UDI
Outer Diameter — 7.0 Millimeter FDA UDI
Outer Diameter — 4.8 Millimeter FDA UDI
Length — 9.2 Millimeter FDA UDI
Outer Diameter — 4.7 Millimeter FDA UDI
Outer Diameter — 4.5 Millimeter FDA UDI
Outer Diameter — 5.8 Millimeter FDA UDI
Length — 13.0 Millimeter FDA UDI
Length — 10.0 Millimeter FDA UDI
Outer Diameter — 5.3 Millimeter FDA UDI
Length — 14.0 Millimeter FDA UDI
Length — 9.6 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI
Length — 11.5 Millimeter FDA UDI
Length — 13.5 Millimeter FDA UDI
Length — 14.5 Millimeter FDA UDI
Outer Diameter — 5.6 Millimeter FDA UDI
Length — 12.5 Millimeter FDA UDI
Height — 8 Millimeter FDA UDI
Outer Diameter — 4.3 Millimeter FDA UDI
Outer Diameter — 5.2 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI
Outer Diameter — 7 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI
Length — 12.2 Millimeter FDA UDI
Height — 4 Millimeter FDA UDI
Outer Diameter — 6.1 Millimeter FDA UDI
Length — 9.5 Millimeter FDA UDI
Length — 9 Millimeter FDA UDI
Length — 7 Millimeter FDA UDI
Outer Diameter — 5.7 Millimeter FDA UDI
Length — 12.1 Millimeter FDA UDI
Length — 9.47 Millimeter FDA UDI
Length — 10.6 Millimeter FDA UDI
Length — 8.6 Millimeter FDA UDI

The Luna Dental Implant System is a dental implant device designed for the placement of endosseous dental implants. It is intended for use in the replacement of missing teeth by integrating with the jawbone to provide stable support for prosthetic crowns, bridges, or dentures.

This system is supplied as a sterile, single-use implant kit and is regulated under FDA 510(k) clearance (K223395) and the Medical Device Directive (MDD). It is intended for use in dental clinics and offices, with components available in standard sizes for various clinical applications. The system adheres to dental implant standards and is classified under product code NHA for endosseous dental implants.

Frequently asked questions

What types of dental restorations can the Luna Dental Implant System support, and how does it integrate with the jawbone?

The Luna Dental Implant System is designed to support prosthetic crowns, bridges, or dentures by integrating with the jawbone through endosseous implantation. This means the implant fuses with the surrounding bone over time, providing stable and long-term support for dental restorations. It is specifically engineered for replacing missing teeth in dental clinics or offices.

Is the Luna Dental Implant System intended for reuse, or is it meant to be used only once per patient?

The Luna Dental Implant System is supplied as a sterile, single-use implant kit. This ensures patient safety and hygiene by preventing cross-contamination between procedures, making it ideal for clinical settings where sterility is critical.

What regulatory pathways does the Luna Dental Implant System follow, and how does this affect its use in clinical settings?

The Luna Dental Implant System is regulated under both the FDA 510(k) clearance (K223395) and the Medical Device Directive (MDD). This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device and meets EU safety and performance standards. Clinicians can rely on its compliance with these regulatory frameworks when integrating it into their practice.

Are there multiple sizes available for the Luna Dental Implant System, and how does this benefit clinicians?

Yes, the Luna Dental Implant System is available in standard sizes tailored for various clinical applications. This flexibility allows clinicians to select the appropriate implant diameter and length based on the patient’s specific anatomical requirements, ensuring a better fit and improved outcomes for dental restoration.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shinhung MST Co., Ltd.

Sources (52)

  • FDA 510(k) K223395 24 fields · synced Oct 6, 2026
  • FDA UDI a8b7eed3-1d6f-4d49-8211-d0f439d99934 37 fields · synced May 22, 2026
  • FDA UDI be0178a4-9334-4216-b646-cabe0275fd8c 37 fields · synced May 22, 2026
  • FDA UDI bacf4d82-1145-490c-b747-0552115c76da 37 fields · synced May 22, 2026
  • FDA UDI 4ea0ffdf-aefc-4367-9fd7-ae976ba8ed94 37 fields · synced May 24, 2026
  • FDA UDI 49263253-28b1-4874-bca1-514cea14e74b 37 fields · synced May 24, 2026
  • FDA UDI 4c7055bd-1e4b-4e75-9661-a137e5c4185a 37 fields · synced May 24, 2026
  • FDA UDI 4d09db8b-629c-41dc-8546-ba2bfa3a5f2c 37 fields · synced May 24, 2026
  • FDA UDI 3b379c0b-df36-43e6-b962-e2895bca509e 37 fields · synced May 25, 2026
  • FDA UDI f424ca5e-79bf-4927-b772-6946c215e5d5 37 fields · synced May 26, 2026
  • FDA UDI 74eaa283-7c7d-482b-a8b2-0da214655f08 37 fields · synced May 27, 2026
  • FDA UDI 5eee2a52-b9bc-4647-aa44-6523b4579eb8 35 fields · synced May 27, 2026
  • FDA UDI a11208d2-71d7-40db-a0d6-791bfa4ae144 37 fields · synced May 29, 2026
  • FDA UDI b0ef1bf4-2fe6-484b-a6ac-5c8a20db4234 37 fields · synced May 29, 2026
  • FDA UDI 82f9c7c7-db12-4d83-a8df-0420d84f9deb 37 fields · synced May 29, 2026
  • FDA UDI 2b9442b7-da2e-4c2e-8baa-06c49b7a159c 37 fields · synced May 29, 2026
  • FDA UDI 0cfb73e2-0434-4c90-b40d-54b65c0de0a8 37 fields · synced May 29, 2026
  • FDA UDI 78c89044-cafa-4a85-9076-4691d1963659 37 fields · synced May 29, 2026
  • FDA UDI 14cc9c7c-d728-46d6-8e48-00eb529b11a0 37 fields · synced May 29, 2026
  • FDA UDI 1ba4a833-59d9-45e4-a45d-334b8dddf739 37 fields · synced May 29, 2026
  • FDA UDI 3dd31b32-132b-45ad-8b2f-92253359a414 35 fields · synced May 29, 2026
  • FDA UDI fbd40315-6109-4447-b94d-77446ab3556f 37 fields · synced May 29, 2026
  • FDA UDI 03f00f18-8993-4ac4-a21e-739513f2be87 37 fields · synced May 29, 2026
  • FDA UDI 42f8f9d9-37b3-46aa-922d-ca341ac2c085 37 fields · synced May 29, 2026
  • FDA UDI 19cc9314-75be-43ab-9a32-0ea3621340c9 35 fields · synced May 29, 2026
  • FDA UDI dac03cce-1518-44d8-a7cf-91dc0dfcee62 37 fields · synced May 29, 2026
  • FDA UDI 602bc453-0b72-4dbe-aff0-5ac1085aca66 37 fields · synced May 29, 2026
  • FDA UDI 79646dcf-10e6-473b-9bbb-752cb2d83df5 37 fields · synced May 29, 2026
  • FDA UDI eba357aa-75a9-4bd4-95f8-e733c9ac0975 37 fields · synced May 29, 2026
  • FDA UDI 5c88fbc4-0c2c-4844-8e8e-cdbbb241651d 37 fields · synced May 29, 2026
  • FDA UDI 7aa87789-397f-44ae-a420-c8692d2db251 37 fields · synced May 29, 2026
  • FDA UDI 474e83df-387f-40d2-92a6-95148e3e656a 37 fields · synced May 29, 2026
  • FDA UDI 9bb8d66d-975e-42fa-bcaa-baa975bbc71f 37 fields · synced May 29, 2026
  • FDA UDI 63db27ea-cd11-4b13-8cb0-c53a55b6dca7 37 fields · synced May 29, 2026
  • FDA UDI 1cb7eef2-4b12-4495-84c7-396f904072ac 37 fields · synced May 29, 2026
  • FDA UDI 706c2bf6-842e-429d-ab19-eb6154f042ec 37 fields · synced May 29, 2026
  • FDA UDI c9bf4d8a-0643-48bc-87c7-84ef99998c02 37 fields · synced May 30, 2026
  • FDA UDI 27768fd2-bff9-4c02-ae62-e72bdbb2908e 37 fields · synced May 30, 2026
  • FDA UDI 4e7ad8ad-34e6-4568-a395-8729c2083b20 37 fields · synced May 30, 2026
  • FDA UDI 6bc24b44-23ca-4062-80b1-067281c7b2e3 37 fields · synced May 30, 2026
  • FDA UDI 71161a09-1287-4c3c-ba93-9c478bb2ad81 37 fields · synced May 30, 2026
  • FDA UDI 9a0152ea-1971-491b-9d30-02e20a6586a5 37 fields · synced May 30, 2026
  • FDA UDI d09e9c05-1888-42b4-bc2c-1d657aad1862 37 fields · synced May 30, 2026
  • FDA UDI 3cae0886-33ca-414e-8956-499959024336 37 fields · synced May 30, 2026
  • FDA UDI 5ec549a5-b83c-4559-9027-a6e2e3909996 35 fields · synced May 30, 2026
  • FDA UDI 1e0ae276-3a4c-4fe4-913d-ec6c6f865532 37 fields · synced May 30, 2026
  • FDA UDI d73f0e8d-9cc8-4768-8f5d-c29c452865f9 37 fields · synced May 30, 2026
  • FDA UDI e9a30929-ebb1-4dab-ace1-81364c0dbc93 37 fields · synced May 30, 2026
  • FDA UDI 63d01714-b279-4dc2-abae-a9aa4d75fbc9 37 fields · synced May 30, 2026
  • FDA UDI e0ca8b04-3eeb-4ce7-8aff-17968b8e7fb5 37 fields · synced May 30, 2026
  • FDA UDI 11792e41-e6ab-47b6-98d9-f190c314fa6f 37 fields · synced May 30, 2026
  • EUDAMED 1 fields · synced Jun 11, 2026