K926458 is an FDA 510(k) clearance for the BIFIX DENTAL CEMENT. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on March 31, 1993, 97 days after receiving the submission on December 24, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K926458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1992 |
| Decision Date | March 31, 1993 |
| Days to Decision | 97 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 |