The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Structur Cad.
| Device ID | K201090 |
| 510k Number | K201090 |
| Device Name: | Structur CAD |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Contact | M. Th. Plaumann |
| Correspondent | T. Gerkensmeier VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-23 |
| Decision Date | 2020-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22160790 | K201090 | 000 |
| E22160780 | K201090 | 000 |
| E22160770 | K201090 | 000 |
| E22160760 | K201090 | 000 |
| E22160731 | K201090 | 000 |
| E22160721 | K201090 | 000 |
| E22160711 | K201090 | 000 |