Enforce Frc™ Enforcekt
Enforce Frc™ Enforcekt is a Class II device made by G&H Wire Company, Inc., cleared under FDA 510(k) K063170 on 12 Jan 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10190886000540), active as of 23 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 | Number10190886000540 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK063170 | Date12 Jan 2007 | StatusActive |
Official records
- AccessGUDID record 10190886000540
- FDA 510(k) database K063170
Across registries
- FDA 510(k) K063170 decided 12 Jan 2007 Active
- FDA GUDID UDI-DI 10190886000540 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K063170
- Listed FDA GUDID 10190886000540
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Enforce Frc™
- Generic name
- Dental reinforcing fibre
- Model / reference
- ENFORCEKT
- Primary DI / UDI-DI
- 10190886000540
- 510(k) Number
- FDA product code
- EBI
- GMDN term
- Dental reinforcing fibre
- Device class
- Class II
- Regulation number
- 872.3760
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dental reinforcing fibre.