Plaquit D38124US
Plaquit D38124US 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 E239D38124US1), 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 | NumberE239D38124US1 | 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 E239D38124US1 listed 16 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K162408
- Listed FDA GUDID E239D38124US1
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- Withdrawn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
- D38124US
- Primary DI / UDI-DI
- E239D38124US1
- 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
Similar devices
Other devices filed under FDA product code EBD (Coating, filling material, resin).
- LED PRO SEAL by RELIANCE ORTHODONTIC PRODUCTS, INC.
- ADHESION PROMOTOR by Lee Pharmaceuticals
- CORE-IDE by ROYDENT DENTAL PRODUCTS INC
- DURAFINISH ALL-CURE, MODEL S296 by PARKELL, INC.
- Curay Join Dent Dentin Primer by SCIENTIFIC PHARMACEUTICALS, INC.
- Myerson/Kenson GP Polymer by Howmedica Corp.
- Parkell Resin Glaze by PARKELL, INC.
- BelleGlass Point 4 by Kerr Dental Materials Center
- SCI-PHARM Paint-on Restorative by SCIENTIFIC PHARMACEUTICALS, INC.
- LUXAGLAZE by Dmg USA, Inc.