The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandioso Light Flow.
| Device ID | K200294 |
| 510k Number | K200294 |
| Device Name: | GrandioSO Light Flow |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Contact | M Th Plaumann |
| Correspondent | T Gerkensmeier VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-05 |
| Decision Date | 2020-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E2212593 | K200294 | 000 |
| E2212592 | K200294 | 000 |
| E2212591 | K200294 | 000 |
| E2212590 | K200294 | 000 |
| E2212589 | K200294 | 000 |
| E2212588 | K200294 | 000 |
| E2212587 | K200294 | 000 |
| E2212586 | K200294 | 000 |
| E2212585 | K200294 | 000 |