The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Twinky Star Nf.
| Device ID | K063604 |
| 510k Number | K063604 |
| Device Name: | TWINKY STAR NF |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-12-04 |
| Decision Date | 2007-01-22 |
| Summary: | summary |