K102128 is an FDA 510(k) clearance for the VITABLOCS. 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 August 11, 2010, 13 days after receiving the submission on July 29, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K102128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2010 |
| Decision Date | August 11, 2010 |
| Days to Decision | 13 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIH - Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |