K210504 is an FDA 510(k) clearance for the PANAVIA Veneer LC. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on June 11, 2021, 109 days after receiving the submission on February 22, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K210504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2021 |
| Decision Date | June 11, 2021 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |