The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Futurabond Dc/single Dose.
Device ID | K070723 |
510k Number | K070723 |
Device Name: | FUTURABOND DC/SINGLE DOSE |
Classification | Agent, Tooth Bonding, Resin |
Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
Contact | Thorsten Gerkensmeier |
Correspondent | Thorsten Gerkensmeier VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-15 |
Decision Date | 2007-06-07 |