TrusFIL Universal Composite Restorative

GUDID 06972220489139

Rizhao HuGe Biomaterials Company, Ltd.

Dental composite resin
Primary Device ID06972220489139
NIH Device Record Keyf25dea08-2c82-45ea-a952-b2e665ae9d6f
Commercial Distribution Discontinuation2023-11-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTrusFIL Universal Composite Restorative
Version Model NumberB1-4g
Company DUNS544452689
Company NameRizhao HuGe Biomaterials Company, Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972220489139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-10
Device Publish Date2023-11-02

On-Brand Devices [TrusFIL Universal Composite Restorative]

06972220489139B1-4g
06972220489085A1-4g

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.