K091894 is an FDA 510(k) clearance for the TEMPORARY C&B COMPOSITE. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on July 23, 2009, 29 days after receiving the submission on June 24, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K091894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2009 |
| Decision Date | July 23, 2009 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |