K231060 is an FDA 510(k) clearance for the ProMin Dental Desensitizing Gel. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on June 13, 2024, 427 days after receiving the submission on April 13, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K231060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2023 |
| Decision Date | June 13, 2024 |
| Days to Decision | 427 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 |