CeraPutty CP10 6010
CeraPutty CP10 6010 is a hygroscopic dental cement (FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by Meta Biomed Co., Ltd., cleared under FDA 510(k) K232299 on 29 Sep 2023 and listed in FDA GUDID since 15 Nov 2023 (UDI-DI 08806387860105), active as of 12 Nov 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 | Number08806387860105 | Date15 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232299 | Date29 Sep 2023 | StatusActive |
Official records
- AccessGUDID record 08806387860105
- FDA 510(k) database K232299
Across registries
- FDA 510(k) K232299 decided 29 Sep 2023 Active
- FDA GUDID UDI-DI 08806387860105 listed 15 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K232299
- Listed FDA GUDID 08806387860105
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CeraPutty CP10
- Generic name
- Hygroscopic dental cement
- Model / reference
- 6010
- Primary DI / UDI-DI
- 08806387860105
- 510(k) Number
- FDA product code
- KIF
- GMDN term
- Hygroscopic dental cement
- Device class
- Class II
- Regulation number
- 872.3820
- GUDID distribution status
- In Commercial Distribution
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