FUTURABOND DC/SINGLE DOSE

Agent, Tooth Bonding, Resin

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Futurabond Dc/single Dose.

Pre-market Notification Details

Device IDK070723
510k NumberK070723
Device Name:FUTURABOND DC/SINGLE DOSE
ClassificationAgent, Tooth Bonding, Resin
Applicant VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
ContactThorsten Gerkensmeier
CorrespondentThorsten Gerkensmeier
VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-15
Decision Date2007-06-07

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