K200155 is an FDA 510(k) clearance for the Bright High Flow. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on November 30, 2020, 313 days after receiving the submission on January 22, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K200155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2020 |
| Decision Date | November 30, 2020 |
| Days to Decision | 313 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 |