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Si

FDA UDI

Class II (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name
SI FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Ball Abutment Ø3.5 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
Model / Reference
SBA35R50 FDA UDI
Description
Ball Abutment Ø3.5 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

Identifiers

Primary DI / UDI-DI
08809458310042 FDA UDI
510(k) Number
K123155 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA 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 UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Height — 3.2 Millimeter FDA UDI
Outer Diameter — 3.6 Millimeter FDA UDI
Length — 14.17 Millimeter FDA UDI

Category: Dental implant suprastructure, permanent, preformed

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

Similar devices

Also classified as Dental implant suprastructure, permanent, preformed.

Cleared under the same submission

K123155 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shinhung MST Co., Ltd.

Sources (1)

  • FDA UDI 1800f712-1e3b-447e-a2d8-f3ee34f10f6a 37 fields · synced May 30, 2026