K190139 is an FDA 510(k) clearance for the Zircos-Com. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Bioden Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 24, 2020, 451 days after receiving the submission on January 29, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K190139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2019 |
| Decision Date | April 24, 2020 |
| Days to Decision | 451 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 |