CLEARFIL VENEER BOND KIT

Material, Tooth Shade, Resin

KURARAY CO.

The following data is part of a premarket notification filed by Kuraray Co. with the FDA for Clearfil Veneer Bond Kit.

Pre-market Notification Details

Device IDK900690
510k NumberK900690
Device Name:CLEARFIL VENEER BOND KIT
ClassificationMaterial, Tooth Shade, Resin
Applicant KURARAY CO. 200 PARK AVE. New York,  NY  10166
ContactShuji Kawai
CorrespondentShuji Kawai
KURARAY CO. 200 PARK AVE. New York,  NY  10166
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-13
Decision Date1990-04-13

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