Copalite 4002
by Temrex Corp.
Copalite 4002 is a Class II device made by Temrex Corp., cleared under FDA 510(k) K851030 on 20 Jun 1985 and listed in FDA GUDID since 2 Mar 2020 (UDI-DI 00850015110290), 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 | Number00850015110290 | Date2 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK851030 | Date20 Jun 1985 | StatusActive |
Official records
- AccessGUDID record 00850015110290
- FDA 510(k) database K851030
Across registries
- FDA 510(k) K851030 decided 20 Jun 1985 Active
- FDA GUDID UDI-DI 00850015110290 listed 2 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K851030
- Listed FDA GUDID 00850015110290
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Copalite
- Generic name
- Dental restorative material varnish
- Model / reference
- 4002
- Primary DI / UDI-DI
- 00850015110290
- 510(k) Number
- FDA product code
- LBH
- GMDN term
- Dental restorative material varnish
- Device class
- Class II
- Regulation number
- 872.3260
- GUDID distribution status
- In Commercial Distribution
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