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Si

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref SIR4010S

by Shinhung MST Co., Ltd.

Identity

Trade Name
LunaSIR4010S EUDAMED
SI FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
Sterile dental implant system EUDAMED
Luna Ø4.0 x 10 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
Model / Reference
SIR4010S EUDAMEDFDA UDI
Description
Luna Ø4.0 x 10 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

Identifiers

Primary DI / UDI-DI
08809457200580 EUDAMEDFDA UDI
Basic UDI-DI
B-08809457200580 EUDAMED
510(k) Number
K123155 FDA UDI
K160106 FDA UDI
FDA Product Code
DZE FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Market of Registration
Türkiye EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 4.2 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Si by Shinhung MST Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Screw endosteal dental implant, two-piece.

Cleared under the same submission

K123155 also covers:

K160106 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shinhung MST Co., Ltd.

Sources (2)

  • FDA UDI 233e69e8-e6da-4d2a-97b3-5f990f8d81c8 37 fields · synced Jun 18, 2026
  • EUDAMED 00bd16c1-f3e0-4fb0-bbc6-7cf9f25c11f1 61 fields · synced Jun 18, 2026