K193434 is an FDA 510(k) clearance for the VITA LUMEX AC. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Vita Zahnfabrik GmbH H Rauter & CO (Bad Sackingen, DE). The FDA issued a Cleared decision on July 21, 2020, 223 days after receiving the submission on December 11, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K193434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2019 |
| Decision Date | July 21, 2020 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH - Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |