K193537 is an FDA 510(k) clearance for the Omnichroma Flow. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on August 19, 2020, 243 days after receiving the submission on December 20, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K193537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2019 |
| Decision Date | August 19, 2020 |
| Days to Decision | 243 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 |