K093446 is an FDA 510(k) clearance for the VITA VMK MASTER. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (Brea, US). The FDA issued a Cleared decision on December 3, 2009, 28 days after receiving the submission on November 5, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K093446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2009 |
| Decision Date | December 03, 2009 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIH - Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |