Dual Cure Resin Cement White (White Opaque) 8g

GUDID 06972220484400

Rizhao HuGe Biomaterials Company, Ltd.

Dental composite resin
Primary Device ID06972220484400
NIH Device Record Key8e7e5e0f-ee18-48f5-a2c9-79e01481cef5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDual Cure Resin Cement
Version Model NumberAutomix
Catalog NumberWhite (White Opaque) 8g
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972220484400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-07
Device Publish Date2021-12-30

On-Brand Devices [Dual Cure Resin Cement]

06972220484363Automix
06972220484417Automix
06972220484400Automix
06972220484394Automix
06972220484387Automix
06972220484370Automix
06972220488644Automix

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