BZF-29

Agent, Tooth Bonding, Resin

GC America Inc.

The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Bzf-29.

Pre-market Notification Details

Device IDK200682
510k NumberK200682
Device Name:BZF-29
ClassificationAgent, Tooth Bonding, Resin
Applicant GC America Inc. 3737 W. 127th Street Alsip,  IL  60803
ContactMark Heiss
CorrespondentMark Heiss
GC America Inc. 3737 W. 127th Street Alsip,  IL  60803
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-16
Decision Date2020-10-02

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