TrusFIL Universal Composite Restorative

Material, Tooth Shade, 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 Trusfil Universal Composite Restorative.

Pre-market Notification Details

Device IDK202063
510k NumberK202063
Device Name:TrusFIL Universal Composite Restorative
ClassificationMaterial, Tooth Shade, 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 CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-27
Decision Date2021-10-06

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