K090644 is an FDA 510(k) clearance for the VITABLOCS, MODEL VX55-****. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Vita Zahnfabrik H.Rauter GmbH & Co. (Brea, US). The FDA issued a Cleared decision on March 31, 2009, 21 days after receiving the submission on March 10, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K090644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2009 |
| Decision Date | March 31, 2009 |
| Days to Decision | 21 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 |