SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow

Material, Tooth Shade, Resin

Kerr Corporation

The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Simplishade Bulk Fill, Simplishade Bulk Fill Flow.

Pre-market Notification Details

Device IDK221255
510k NumberK221255
Device Name:SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
ClassificationMaterial, Tooth Shade, Resin
Applicant Kerr Corporation 1889 W Mission Blvd Pomona,  CA  91766
ContactHaiyan Wei
CorrespondentHaiyan Wei
Kerr Corporation 1889 W Mission Blvd Pomona,  CA  91766
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-08-31

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