Renamel Bulkfill

Material, Tooth Shade, Resin

Cosmedent, Inc

The following data is part of a premarket notification filed by Cosmedent, Inc with the FDA for Renamel Bulkfill.

Pre-market Notification Details

Device IDK211259
510k NumberK211259
Device Name:Renamel Bulkfill
ClassificationMaterial, Tooth Shade, Resin
Applicant Cosmedent, Inc 401 North Michigan Avenue, Suite 2500 Chicago,  IL  60611
ContactGary Chuven
CorrespondentGary Chuven
Cosmedent, Inc 401 N Michigan Ave, Suite 2500 Chicago,  IL  60611
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-06-24

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