K231263 is an FDA 510(k) clearance for the Fusion Core DC Flo. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on January 5, 2024, 248 days after receiving the submission on May 2, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K231263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2023 |
| Decision Date | January 05, 2024 |
| Days to Decision | 248 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 |