K113040 is an FDA 510(k) clearance for the CERAMIR CROWN & BRIDGE. 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 December 28, 2011, 77 days after receiving the submission on October 12, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K113040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2011 |
| Decision Date | December 28, 2011 |
| Days to Decision | 77 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA - Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |