HC Primer

Agent, Tooth Bonding, Resin

Shofu Dental Corporation

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

Pre-market Notification Details

Device IDK161891
510k NumberK161891
Device Name:HC Primer
ClassificationAgent, Tooth Bonding, 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 CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-11
Decision Date2016-11-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E235Y00050 K161891 000

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