K211345 is an FDA 510(k) clearance for the C-30 Crown Kit. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Perfect Fit Crowns, LLC (Royal Palm Beach, US). The FDA issued a Cleared decision on November 24, 2021, 205 days after receiving the submission on May 3, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K211345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2021 |
| Decision Date | November 24, 2021 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |