K243940 is an FDA 510(k) clearance for the VITA YZ Multi Translucent. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Vita Zahnfabrik H.Rauter GmbH & Co. (Bad Sackingen, DE). The FDA issued a Cleared decision on February 21, 2025, 63 days after receiving the submission on December 20, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K243940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2024 |
| Decision Date | February 21, 2025 |
| Days to Decision | 63 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 |