K203598 is an FDA 510(k) clearance for the Omnichroma Flow Bulk. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Tokuyama Dental Corporation (Taitou-Ku, JP). The FDA issued a Cleared decision on February 3, 2021, 56 days after receiving the submission on December 9, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K203598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2020 |
| Decision Date | February 03, 2021 |
| Days to Decision | 56 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 |