K201937 is an FDA 510(k) clearance for the Ceramir Restore QuikCap. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Doxa Dental AB (Uppsala, SE). The FDA issued a Cleared decision on November 13, 2020, 123 days after receiving the submission on July 13, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K201937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2020 |
| Decision Date | November 13, 2020 |
| Days to Decision | 123 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA - Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |