K211854 is an FDA 510(k) clearance for the VITA Akzent LC. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by Vita Zahnfabrik GmbH H Rauter & CO (Bad Sackingen, DE). The FDA issued a Cleared decision on November 22, 2021, 159 days after receiving the submission on June 16, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K211854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2021 |
| Decision Date | November 22, 2021 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBD - Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |