CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER

Cement, Dental

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Chameleon Light/chemical Cure Glass Ionomer.

Pre-market Notification Details

Device IDK930455
510k NumberK930455
Device Name:CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER
ClassificationCement, Dental
Applicant VOCO GMBH 7527 WESTMORELAND AVE. St. Louis,  MO  63105
ContactEvan G Dick
CorrespondentEvan G Dick
VOCO GMBH 7527 WESTMORELAND AVE. St. Louis,  MO  63105
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-27
Decision Date1993-04-08

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