CeraPutty
510(k) K232299
CeraPutty is a medical device (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, 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 | FDA 510(k)SESE | NumberK232299 | Date29 Sep 2023 | StatusActive |
Official records
- FDA 510(k) database K232299
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KIF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3820
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232299
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CeraPutty CP05 6011 | 6011 | 08806387860112 | — | On the market |
| CeraPutty CP10 6010 | 6010 | 08806387860105 | — | On the market |
Similar devices
Other devices filed under FDA product code KIF (Resin, Root Canal Filling).
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