K924982 is an FDA 510(k) clearance for the CONSEPSIS(TM). This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 8, 1993, 280 days after receiving the submission on October 1, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K924982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1992 |
| Decision Date | July 08, 1993 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |