K181965 is an FDA 510(k) clearance for the Restore Toothpaste. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Dr. Collins, Inc. (Irvine, US). The FDA issued a Cleared decision on June 13, 2019, 325 days after receiving the submission on July 23, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K181965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2018 |
| Decision Date | June 13, 2019 |
| Days to Decision | 325 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 |