The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Consepsis Scrub.
| Device ID | K925375 |
| 510k Number | K925375 |
| Device Name: | CONSEPSIS SCRUB |
| Classification | Varnish, Cavity |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Nancy Simons |
| Correspondent | Nancy Simons ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-23 |
| Decision Date | 1993-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205105912 | K925375 | 000 |
| 00883205105820 | K925375 | 000 |
| 00883205103789 | K925375 | 000 |
| 00883205103772 | K925375 | 000 |