Light Cure Dental Adhesive

Agent, Tooth Bonding, Resin

Rizhao HuGe Biomaterials Company, Ltd.

The following data is part of a premarket notification filed by Rizhao Huge Biomaterials Company, Ltd. with the FDA for Light Cure Dental Adhesive.

Pre-market Notification Details

Device IDK201787
510k NumberK201787
Device Name:Light Cure Dental Adhesive
ClassificationAgent, Tooth Bonding, Resin
Applicant Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District Of Donggang Rizhao City,  CN 276800
ContactMaggie Zheng
CorrespondentMaggie Zheng
Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District Of Donggang Rizhao City,  CN 276800
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-30
Decision Date2020-09-25

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