K042823 is an FDA 510(k) clearance for the COSMEDENT PIT & FISSURE SEALANT. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on December 1, 2004, 50 days after receiving the submission on October 12, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K042823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2004 |
| Decision Date | December 01, 2004 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |