The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio Flow Try-in.
| Device ID | K062343 |
| 510k Number | K062343 |
| Device Name: | GRANDIO FLOW TRY-IN |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Michael Sues |
| Correspondent | Michael Sues VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-11 |
| Decision Date | 2006-11-02 |
| Summary: | summary |