Consepsis(Tm)
510(k) K924982
Consepsis(Tm) is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K924982 on 8 Jul 1993, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924982 | Date8 Jul 1993 | StatusActive |
Official records
- FDA 510(k) database K924982
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LBH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3260
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K924982
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Consepsis 404 | 404 / 404 | 00883205105615 | — | On the market |
| Consepsis 4614 | 4614 / 4614 | 00883205106704 | — | On the market |
| Consepsis 490 | 490 / 490 | 00883205103581 | — | On the market |
| Consepsis 491 | 491 / 491 | 00883205102669 | — | On the market |
| Consepsis 687 | 687 / 687 | 00883205105905 | — | On the market |
| Consepsis 7665 | 7665 / 7665 | 00883205102607 | — | On the market |
Similar devices
Other devices filed under FDA product code LBH (Varnish, Cavity).
- 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment by 3M Espe AG Dental Products
- Profisil 14825 by Kettenbach GmbH & Co. KG
- TUBULITEC PRIMER by Dental Therapeutics AB
- MICRODOSE POTASSIUM OXYLATE by Unicep
- Clinpro Varnish by 3M COMPANY
- ESPE VARNISH by Espe GmbH (Us)
- VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 by 3M COMPANY
- SCI-PHARM DESENSITIZING VARNISH by SCIENTIFIC PHARMACEUTICALS, INC.
- ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT by Adpharma, Inc.
- PRG BARRIER COAT by SHOFU DENTAL CORP.