K231338 is an FDA 510(k) clearance for the 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on May 10, 2023, 2 days after receiving the submission on May 8, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K231338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2023 |
| Decision Date | May 10, 2023 |
| Days to Decision | 2 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LBH - Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |