The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio Flow.
| Device ID | K051868 |
| 510k Number | K051868 |
| Device Name: | GRANDIO FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps VOCO GMBH 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-11 |
| Decision Date | 2005-07-27 |