K143212 is an FDA 510(k) clearance for the Bifix Temp. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on May 1, 2015, 172 days after receiving the submission on November 10, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K143212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2014 |
| Decision Date | May 01, 2015 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |