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 |