The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio So Flow.
| Device ID | K103580 |
| 510k Number | K103580 |
| Device Name: | GRANDIO SO FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Manfred Thomas Plaumann |
| Correspondent | Manfred Thomas Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22127491 | K103580 | 000 |
| E22127231 | K103580 | 000 |
| E22127241 | K103580 | 000 |
| E22127251 | K103580 | 000 |
| E22127261 | K103580 | 000 |
| E22127271 | K103580 | 000 |
| E22127291 | K103580 | 000 |
| E22127301 | K103580 | 000 |
| E22127321 | K103580 | 000 |
| E22127331 | K103580 | 000 |
| E22127341 | K103580 | 000 |
| E22127361 | K103580 | 000 |
| E22127371 | K103580 | 000 |
| E22127421 | K103580 | 000 |
| E22127431 | K103580 | 000 |
| E22127441 | K103580 | 000 |
| E22127451 | K103580 | 000 |
| E22127461 | K103580 | 000 |
| E22127221 | K103580 | 000 |