Klockner SK2-4218
Klockner SK2-4218 is a Class II device made by Soadco, S.L., cleared under FDA 510(k) K010132 on 4 Jun 2002 and listed in FDA GUDID since 22 Nov 2022 (UDI-DI 08435451614674), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08435451614674 | Date22 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK010132 | Date4 Jun 2002 | StatusActive |
Official records
- AccessGUDID record 08435451614674
- FDA 510(k) database K010132
Across registries
- FDA 510(k) K010132 decided 4 Jun 2002 Active
- FDA GUDID UDI-DI 08435451614674 listed 22 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K010132
- Listed FDA GUDID 08435451614674
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Klockner
- Generic name
- Screw endosteal dental implant, one-piece
- Model / Ref / Catalog
- SK2-4218
- Primary DI / UDI-DI
- 08435451614674
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Screw endosteal dental implant, one-piece
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution