Gel Etch 6500 Kit
by Temrex Corp.
Gel Etch 6500 Kit is a Class II device made by Temrex Corp., cleared under FDA 510(k) K872569 on 21 Jul 1987 and listed in FDA GUDID since 12 Feb 2020 (UDI-DI 00850015110375), 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 | Number00850015110375 | Date12 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK872569 | Date21 Jul 1987 | StatusActive |
Official records
- AccessGUDID record 00850015110375
- FDA 510(k) database K872569
Across registries
- FDA 510(k) K872569 decided 21 Jul 1987 Active
- FDA GUDID UDI-DI 00850015110375 listed 12 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K872569
- Listed FDA GUDID 00850015110375
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gel Etch
- Generic name
- Dental tooth-etching solution
- Model / reference
- 6500 KIT
- Primary DI / UDI-DI
- 00850015110375
- 510(k) Number
- FDA product code
- EBF
- GMDN term
- Dental tooth-etching solution
- Device class
- Class II
- Regulation number
- 872.3690
- GUDID distribution status
- In Commercial Distribution
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