BeautiCem Veneer Kit

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 Beauticem Veneer Kit.

Pre-market Notification Details

Device IDK180649
510k NumberK180649
Device Name:BeautiCem Veneer Kit
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 Received2018-03-13
Decision Date2018-06-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E235C00130 K180649 000
E235C00040 K180649 000
E235C00050 K180649 000
E235C00060 K180649 000
E235C00070 K180649 000
E235C00080 K180649 000
E235C00090 K180649 000
E235C00100 K180649 000
E235C00110 K180649 000
E235C00120 K180649 000
E235C00020 K180649 000

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