K191991 is an FDA 510(k) clearance for the Ezfil. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Meta Biomed Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on March 5, 2020, 224 days after receiving the submission on July 25, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K191991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2019 |
| Decision Date | March 05, 2020 |
| Days to Decision | 224 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 |