Cerasmart® 008346
Cerasmart® 008346 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K133824 on 14 Mar 2014 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470083461), active as of 22 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 | NumberD0470083461 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133824 | Date14 Mar 2014 | StatusActive |
Official records
- FDA 510(k) database K133824
Across registries
- FDA 510(k) K133824 decided 14 Mar 2014 Active
- FDA GUDID UDI-DI D0470083461 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K133824
- Listed FDA GUDID D0470083461
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cerasmart®
- Generic name
- Dental implant suprastructure, permanent, preformed
- Model / Ref / Catalog
- 008346
- Primary DI / UDI-DI
- D0470083461
- 510(k) Number
- FDA product code
- EBF, EBG
- GMDN term
- Dental implant suprastructure, permanent, preformed
- Device class
- Class II
- Regulation number
- 872.3690, 872.3770
- GUDID distribution status
- In Commercial Distribution
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