Preat 710214
Preat 710214 is a Class II device made by PREAT Corporation, cleared under FDA 510(k) K222288 on 27 Oct 2022 and listed in FDA GUDID since 24 Jul 2025 (UDI-DI 00842092184509), 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 | Number00842092184509 | Date24 Jul 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222288 | Date27 Oct 2022 | StatusActive |
Official records
- AccessGUDID record 00842092184509
- FDA 510(k) database K222288
Across registries
- FDA 510(k) K222288 decided 27 Oct 2022 Active
- FDA GUDID UDI-DI 00842092184509 listed 24 Jul 2025 Listed
Timeline
- Cleared FDA 510(k) K222288
- Listed FDA GUDID 00842092184509
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Preat
- Generic name
- Dental implant suprastructure, permanent, preformed
- Model / Ref / Catalog
- 710214
- Description
- PreatLoc™ Astra®-compatible Aqua Abutment 4mm
- Primary DI / UDI-DI
- 00842092184509
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant suprastructure, permanent, preformed
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional