s-Clean TiN Half Coating Angled Abutment

FDA UDI

Class II (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name: s-Clean TiN Half Coating Angled Abutment FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: Dental Implant System / s-Clean TiN Half Coating Angled Abutment Set (Abutment + Abutment Screw) FDA UDI
Model / Reference: DSAA45152NHCTS FDA UDI
Description: Dental Implant System / s-Clean TiN Half Coating Angled Abutment Set (Abutment + Abutment Screw) FDA UDI

Identifiers

Primary DI / UDI-DI: 08806169199867 FDA UDI
510(k) Number: K171694 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Category: Dental implant suprastructure, permanent, preformed

A comprehensive medical device directory entry for the s-Clean TiN Half Coating Angled Abutment. This device is a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture), made of titanium (Ti) or various materials such as plastic or gold alloy.

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GS System — OSSTEM IMPLANT Co., Ltd. · Class II
Temporary Abutment — Cybermed Inc. · Class II
EZ Post — Megagen Implant Co. Ltd · Class II

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

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Manufacturer

Manufacturer: Dentis Co. , Ltd

Sources (1)

FDA UDI 3d6c3e90-a855-4973-a379-7c4cde1a6bf6 34 fields · synced Jul 12, 2026

s-Clean TiN Half Coating Angled Abutment

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)