SHOFU BLOCK HC

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.

Pre-market Notification Details

Device IDK130841
510k NumberK130841
Device Name:SHOFU BLOCK HC
ClassificationMaterial, Tooth Shade, Resin
Applicant SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos,  CA  92078
ContactDavid P Morais
CorrespondentDavid P Morais
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 Received2013-03-26
Decision Date2013-09-11

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