The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Cimara.
| Device ID | K110589 |
| 510k Number | K110589 |
| Device Name: | CIMARA |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE 27472 |
| Contact | Manfred T Plaumann |
| Correspondent | Manfred T Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE 27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-02 |
| Decision Date | 2011-05-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CIMARA 79093929 3996018 Dead/Cancelled |
VOCO GmbH 2010-12-22 |