Si

FDA UDI

Class II (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name: SI FDA UDI
Generic Name: Dental implant suprastructure kit FDA UDI
Device Name: Screw Abutment Titanium Cylinder Φ5.5 Bridge It is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect. FDA UDI
Model / Reference: STC55B FDA UDI
Description: Screw Abutment Titanium Cylinder Φ5.5 Bridge It is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809458316822 FDA UDI
510(k) Number: K123155 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure kit 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.5 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI

Category: Dental implant suprastructure kit

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 kit.

KLOCKNER — SOADCO, S.L. · Class I
KLOCKNER — SOADCO, S.L. · Class II
ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw) — CeramTec Schweiz GmbH · Class II
KLOCKNER — SOADCO, S.L. · Class II
CERALOG® PL Abutment 15° angled, Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH · Class II
KLOCKNER — SOADCO, S.L. · Class II
Prosthetic Accessories — A.B. DENTAL DEVICES LTD · Class II
KLOCKNER — SOADCO, S.L. · Class II

Cleared under the same submission

K123155 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Shinhung MST Co., Ltd.

Sources (1)

FDA UDI 45dd256f-d1f5-4e7f-96a3-8c791a5a731c 37 fields · synced May 31, 2026