K163346 is an FDA 510(k) clearance for the MAZIC Duro. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on March 17, 2017, 108 days after receiving the submission on November 29, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K163346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2016 |
| Decision Date | March 17, 2017 |
| Days to Decision | 108 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 |