Plaquit D38123US
Plaquit D38123US is a Class II device made by Dreve Dentamid GmbH, cleared under FDA 510(k) K162408 on 5 Apr 2018 and listed in FDA GUDID since 16 Apr 2024 (UDI-DI E239D38123US1), 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 | NumberE239D38123US1 | Date16 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162408 | Date5 Apr 2018 | StatusActive |
Official records
- FDA 510(k) database K162408
Across registries
- FDA 510(k) K162408 decided 5 Apr 2018 Active
- FDA GUDID UDI-DI E239D38123US1 listed 16 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K162408
- Listed FDA GUDID E239D38123US1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Plaquit
- Generic name
- Dental restorative material varnish
- Model / Ref / Catalog
- D38123US
- Primary DI / UDI-DI
- E239D38123US1
- 510(k) Number
- FDA product code
- EBD
- GMDN term
- Dental restorative material varnish
- Device class
- Class II
- Regulation number
- 872.3310
- GUDID distribution status
- In Commercial Distribution
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