Identity
- Trade Name
- s-Clean TiN Partial Coating Couple Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Implant System / s-Clean TiN Partial Coating Couple Abutment D4.8mm, Cuff2.3mm / Non-Hex FDA UDI
- Model / Reference
- DSCA482NPCT FDA UDI
- Description
- Dental Implant System / s-Clean TiN Partial Coating Couple Abutment D4.8mm, Cuff2.3mm / Non-Hex FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169168641 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
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
s-Clean TiN Partial Coating Couple Abutment by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K171694 also covers:
- s-Clean Abutment Screw — DENTIS CO. , LTD
- s-Clean Hex Abutment — DENTIS CO. , LTD
- s-Clean Sole Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD
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 66886daf-b63a-4df9-8881-808af9912632 34 fields · synced May 31, 2026