K200470 is an FDA 510(k) clearance for the Shofu Block HC Hard. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on February 5, 2021, 345 days after receiving the submission on February 26, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K200470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2020 |
| Decision Date | February 05, 2021 |
| Days to Decision | 345 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 |