Shofu Block HC Hard

Material, Tooth Shade, Resin

Shofu Dental Corporation

The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Shofu Block Hc Hard.

Pre-market Notification Details

Device IDK200470
510k NumberK200470
Device Name:Shofu Block HC Hard
ClassificationMaterial, Tooth Shade, Resin
Applicant Shofu Dental Corporation 1225 Stone Drive San Marcos,  CA  92078
ContactMauro Malzyner
CorrespondentMauro Malzyner
Shofu Dental Corporation 1225 Stone Drive San Marcos,  CA  92078
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-26
Decision Date2021-02-05

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