Identity
- Trade Name
- s-Clean TiN Half Coating Angled Abutment FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Dental Implant System / s-Clean TiN Half Coating Angled Abutment D5.5mm, Cuff3.8mm, Angulation25° / Non-Hex FDA UDI
- Model / Reference
- DSAA552547NHCT FDA UDI
- Description
- Dental Implant System / s-Clean TiN Half Coating Angled Abutment D5.5mm, Cuff3.8mm, Angulation25° / Non-Hex FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169115720 FDA UDI
- 510(k) Number
- K171694 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece 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
Category: Screw endosteal dental implant, two-piece
s-Clean TiN Half Coating Angled Abutment by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
- ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
- LW Solid Abutment — Ossvis Co., Ltd. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II
- UF(II) Wide — DIO Corporation · 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 63ea1b0e-1077-4f54-b042-0d992e079116 34 fields · synced Jun 6, 2026