Klockner 8050
by Soadco, S.L.
Klockner 8050 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 23 Feb 2023 (UDI-DI 08435451609601), 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 | Number08435451609601 | Date23 Feb 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK010132 | Date4 Jun 2002 | StatusActive |
Official records
- AccessGUDID record 08435451609601
- FDA 510(k) database K010132
Across registries
- FDA 510(k) K010132 decided 4 Jun 2002 Active
- FDA GUDID UDI-DI 08435451609601 listed 23 Feb 2023 Listed
Timeline
- Cleared FDA 510(k) K010132
- Listed FDA GUDID 08435451609601
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Klockner
- Generic name
- Overdenture
- Model / Ref / Catalog
- 8050
- Primary DI / UDI-DI
- 08435451609601
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Overdenture
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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