BEAUTIFIL II Enamel

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 Beautifil Ii Enamel.

Pre-market Notification Details

Device IDK151699
510k NumberK151699
Device Name:BEAUTIFIL II Enamel
ClassificationMaterial, Tooth Shade, Resin
Applicant SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos,  CA  92078
ContactMauro Malyzyner
CorrespondentMauro Malyzyner
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 Received2015-06-24
Decision Date2015-12-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E235Y22530 K151699 000
E235Y22520 K151699 000
E235Y22510 K151699 000
E235Y22500 K151699 000

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