Consepsis Scrub
510(k) K925375
Consepsis Scrub is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K925375 on 22 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 | NumberK925375 | Date22 Jul 1993 | StatusActive |
Official records
- FDA 510(k) database K925375
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- Withdrawn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 K925375
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 546 | 546 / 546 | 00883205032812 | — | On the market |
| Consepsis 546 | 546 / 546 | 00883205105820 | — | On the market |
| Consepsis 689 | 689 / 689 | 00883205032829 | — | On the market |
| Consepsis 689 | 689 / 689 | 00883205105912 | — | On the market |
| Consepsis 730 | 730 / 730 | 00883205103789 | — | On the market |
| Consepsis 732 | 732 / 732 | 00883205103772 | — | On the market |
| Consepsis 732 | 732 / 732 | 00883205032843 | — | On the market |
Similar devices
Other devices filed under FDA product code LBH (Varnish, Cavity).
- DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor by SCIENTIFIC PHARMACEUTICALS, INC.
- TOKUYAMA SHIELD FORCE by TOKUYAMA DENTAL CORPORATION
- VIVASENS by Ivoclar Vivadent, Inc.
- KATANA Cleaner #3970-KA by KURARAY NORITAKE DENTAL INC.
- Fluoride Varnish (Type A) by Nagy Oral Technology Qinhuangdao Co., Ltd.
- DENSHIELD TREATMENT FOR SENSITIVE TEETH by Novamin Technology, Inc.
- Pulpdent Cavity Preparation III by Pulpdent Corporation
- UNIVAR UNIVERSAL DENTIN VARNISH by SCIENTIFIC PHARMACEUTICALS, INC.
- Dental Desensitizer by Guangzhou Beogene Biotech Co., Ltd.
- CONTAC, A DENTIN SEALANT by Harry J. Bosworth Co.