The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Temporary C&b Composite.
Device ID | K091894 |
510k Number | K091894 |
Device Name: | TEMPORARY C&B COMPOSITE |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
Contact | T. Gerkensmeier |
Correspondent | T. Gerkensmeier VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-24 |
Decision Date | 2009-07-23 |