Light Cure Dental Adhesive 5ml

GUDID 06972220484301

Rizhao HuGe Biomaterials Company, Ltd.

Dentine bonding agent/set
Primary Device ID06972220484301
NIH Device Record Keybc374b24-b8e3-4d10-a875-ec62228c5d43
Commercial Distribution StatusIn Commercial Distribution
Brand NameLight Cure Dental Adhesive
Version Model Number/
Catalog Number5ml
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
GS106972220484301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-23
Device Publish Date2021-12-15

Devices Manufactured by Rizhao HuGe Biomaterials Company, Ltd.

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06972220489085 - TrusFIL Universal Composite Restorative2023-11-10
06972220489139 - TrusFIL Universal Composite Restorative2023-11-10
06972220484370 - Dual Cure Resin Cement2022-01-07
06972220484387 - Dual Cure Resin Cement2022-01-07
06972220484394 - Dual Cure Resin Cement2022-01-07

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