Preat 710483
Preat 710483 is a Class II device made by PREAT Corporation, cleared under FDA 510(k) K251547 on 31 Oct 2025 and listed in FDA GUDID since 22 Dec 2025 (UDI-DI 00842092184875), 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 | Number00842092184875 | Date22 Dec 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK251547 | Date31 Oct 2025 | StatusActive |
Official records
- AccessGUDID record 00842092184875
- FDA 510(k) database K251547
Across registries
- FDA 510(k) K251547 decided 31 Oct 2025 Active
- FDA GUDID UDI-DI 00842092184875 listed 22 Dec 2025 Listed
Timeline
- Cleared FDA 510(k) K251547
- Listed FDA GUDID 00842092184875
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- Withdrawn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
- 710483
- Description
- PreatLoc™ Ankylos®-compatible C/X Abutment 3mm
- Primary DI / UDI-DI
- 00842092184875
- 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