K223365 is an FDA 510(k) clearance for the RODIN Palette Naturalizing Kit. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on March 27, 2023, 144 days after receiving the submission on November 3, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K223365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2022 |
| Decision Date | March 27, 2023 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBD - Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |