Coltosol F 5916
Coltosol F 5916 is a Class II device made by Coltène/Whaledent AG, cleared under FDA 510(k) K031752 on 5 Aug 2003 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI J00659160), 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 | NumberJ00659160 | Date15 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031752 | Date5 Aug 2003 | StatusActive |
Official records
- FDA 510(k) database K031752
Across registries
- FDA 510(k) K031752 decided 5 Aug 2003 Active
- FDA GUDID UDI-DI J00659160 listed 15 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K031752
- Listed FDA GUDID J00659160
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Coltosol F
- Generic name
- Zinc phosphate dental cement
- Model / Ref / Catalog
- 5916
- Primary DI / UDI-DI
- J00659160
- 510(k) Number
- FDA product code
- EMA
- GMDN term
- Zinc phosphate dental cement
- Device class
- Class II
- Regulation number
- 872.3275
- GUDID distribution status
- In Commercial Distribution
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