The following data is part of a premarket notification filed by Kulzer, Llc with the FDA for Venus Bulk Flow One.
| Device ID | K220605 |
| 510k Number | K220605 |
| Device Name: | Venus Bulk Flow ONE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Kulzer, LLC 4315 S. Lafayette Blvd South Bend, IN 46614 |
| Contact | Marc Henn |
| Correspondent | Marc Henn Kulzer, LLC 4315 S. Lafayette Blvd South Bend, IN 46614 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-02 |
| Decision Date | 2022-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660953350 | K220605 | 000 |
| J014660947240 | K220605 | 000 |
| J014660947230 | K220605 | 000 |
| J014660982790 | K220605 | 000 |