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Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ40504N)
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K171027
Identity
- Trade Name
- Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ40504N) FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ40504N) FDA UDI
- Model / Reference
- DSCAMZ40504N FDA UDI
- Description
- Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ40504N) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053025560 FDA UDI
- 510(k) Number
- K210080 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
Category: Dental implant suprastructure, permanent, preformed
Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ40504N) by Dentis Co. , Ltd — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k)
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
K210080 also covers:
- s-Clean Angled Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Angled Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Angled Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Angled Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Angled Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Angled Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Couple Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Couple Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Couple Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Couple Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Couple Abutment s-Line Mini — DENTIS CO. , LTD
- s-Clean Couple Abutment s-Line Mini — DENTIS CO. , LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150344 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K073486 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171027 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
- FDA Applicant
- Dentis Co., Ltd.
Sources (2)
- FDA UDI 56c6eaea-8fd5-4b68-b705-b06aea3fe69d 58 fields · synced Jun 18, 2026
- FDA 510(k) K150344 1 fields · synced Jun 5, 2026