Fiber-Bond 1x3ml 5973
Fiber-Bond 1x3ml 5973 is a Class II device made by Polydentia SA, cleared under FDA 510(k) K962374 on 22 Jul 1996 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI E29959730), 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 | NumberE29959730 | Date28 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK962374 | Date22 Jul 1996 | StatusActive |
Official records
- FDA 510(k) database K962374
Across registries
- FDA 510(k) K962374 decided 22 Jul 1996 Active
- FDA GUDID UDI-DI E29959730 listed 28 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K962374
- Listed FDA GUDID E29959730
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fiber-Bond 1x3ml
- Generic name
- Dentine bonding agent/set
- Model / reference
- 5973
- Primary DI / UDI-DI
- E29959730
- 510(k) Number
- FDA product code
- EBI
- GMDN term
- Dentine bonding agent/set
- Device class
- Class II
- Regulation number
- 872.3760
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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