The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Twinky Star.
| Device ID | K022797 |
| 510k Number | K022797 |
| Device Name: | TWINKY STAR |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-23 |
| Decision Date | 2002-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22117191 | K022797 | 000 |
| E22116811 | K022797 | 000 |
| E22116821 | K022797 | 000 |
| E22116831 | K022797 | 000 |
| E22116841 | K022797 | 000 |
| E22116851 | K022797 | 000 |
| E22116861 | K022797 | 000 |
| E22116871 | K022797 | 000 |
| E22116881 | K022797 | 000 |
| E22117121 | K022797 | 000 |
| E22117131 | K022797 | 000 |
| E22117141 | K022797 | 000 |
| E22117151 | K022797 | 000 |
| E22117161 | K022797 | 000 |
| E22117171 | K022797 | 000 |
| E22117181 | K022797 | 000 |
| E22116801 | K022797 | 000 |