Regennex-Etchant / Cleanser 90719-2
by Vista Dental
Regennex-Etchant / Cleanser 90719-2 is a Class II device made by Vista Dental, cleared under FDA 510(k) K061981 on 31 Jul 2006 and listed in FDA GUDID since 29 Jan 2021 (UDI-DI 10818207020557), 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 | Number10818207020557 | Date29 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061981 | Date31 Jul 2006 | StatusActive |
Official records
- AccessGUDID record 10818207020557
- FDA 510(k) database K061981
Across registries
- FDA 510(k) K061981 decided 31 Jul 2006 Active
- FDA GUDID UDI-DI 10818207020557 listed 29 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K061981
- Listed FDA GUDID 10818207020557
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Regennex-Etchant / Cleanser
- Generic name
- Dentine bonding agent/set
- Model / reference
- 90719-2
- Primary DI / UDI-DI
- 10818207020557
- 510(k) Number
- FDA product code
- KLE
- GMDN term
- Dentine bonding agent/set
- Device class
- Class II
- Regulation number
- 872.3200
- GUDID distribution status
- In Commercial Distribution
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