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Dental Implantation Systems
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref C-Sailor510(k) K220831
Identity
- Device Name
- Dental Implantation Systems EUDAMED
- Model / Reference
- C-Sailor EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974267890589 EUDAMED
- Basic UDI-DI
- B-06974267890589 EUDAMED
- 510(k) Number
- K220831 FDA 510(k)
- FDA Product Code
- EBW FDA 510(k)
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4200 FDA 510(k)
- Regulation Number
- 872.4200 FDA 510(k)
- Market of Registration
- Romania EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Implantation Systems by Foshan COXO Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220831 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06974267890589 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan COXO Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001682
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED e251cb96-17bc-428b-8173-6d459a6ec229 61 fields · synced Oct 6, 2026
- FDA 510(k) K220831 24 fields · synced May 18, 2026