K210412 is an FDA 510(k) clearance for the Pac-Dent Ceramic Nanohybrid Resin. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on July 26, 2021, 165 days after receiving the submission on February 11, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K210412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2021 |
| Decision Date | July 26, 2021 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |