K200077 is an FDA 510(k) clearance for the BioMin Restore Plus. 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 November 6, 2020, 297 days after receiving the submission on January 14, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K200077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2020 |
| Decision Date | November 06, 2020 |
| Days to Decision | 297 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 |