The following data is part of a premarket notification filed by Rizhao Huge Biomaterials Company, Ltd. with the FDA for Trusfil Universal Composite Restorative.
|Device Name:||TrusFIL Universal Composite Restorative|
|Classification||Material, Tooth Shade, Resin|
|Applicant||Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District Of Donggang Rizhao City, CN 276800|
Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District Of Donggang Rizhao City, CN 276800
|CFR Regulation Number||872.3690 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|