Consepsis 546
by Ultradent Products, Inc. 2 variants
Consepsis 546 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K925375 on 22 Jul 1993 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205105820), 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 | Number00883205105820 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK925375 | Date22 Jul 1993 | StatusActive |
Official records
- AccessGUDID record 00883205105820
- FDA 510(k) database K925375
Across registries
- FDA 510(k) K925375 decided 22 Jul 1993 Active
- FDA GUDID UDI-DI 00883205105820 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K925375
- Listed FDA GUDID 00883205105820
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Consepsis
- Generic name
- Dental tooth-cleaning solution
- Model / Ref / Catalog
- 546
- Primary DI / UDI-DI
- 00883205105820
- 510(k) Number
- FDA product code
- LBH
- GMDN term
- Dental tooth-cleaning solution
- Device class
- Class II
- Regulation number
- 872.3260
- GUDID distribution status
- In Commercial Distribution
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