K220605 is an FDA 510(k) clearance for the Venus Bulk Flow ONE. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on April 21, 2022, 50 days after receiving the submission on March 2, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K220605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2022 |
| Decision Date | April 21, 2022 |
| Days to Decision | 50 days |
| Submission Type | Special |
| 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 |