K110050 is an FDA 510(k) clearance for the FIT TEST C&B. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on March 28, 2011, 80 days after receiving the submission on January 7, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K110050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2011 |
| Decision Date | March 28, 2011 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |