K214086 is an FDA 510(k) clearance for the Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on December 15, 2022, 353 days after receiving the submission on December 27, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K214086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | December 15, 2022 |
| Days to Decision | 353 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |