BEAUTICEM SA

Cement, Dental

SHOFU DENTAL CORPORATION

The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beauticem Sa.

Pre-market Notification Details

Device IDK120159
510k NumberK120159
Device Name:BEAUTICEM SA
ClassificationCement, Dental
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 CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-19
Decision Date2012-06-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E23532140 K120159 000
E23532130 K120159 000

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