TNE

GUDID 00850015110054

Resin Based Dental Cement

TEMREX CORPORATION

Dental acrylic resin
Primary Device ID00850015110054
NIH Device Record Keyeeed006c-7108-4d95-aff9-f8020abe59b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTNE
Version Model Number7760
Company DUNS012072823
Company NameTEMREX CORPORATION
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 Usetrue
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
GS100850015110054 [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 Date2020-01-22
Device Publish Date2020-01-14

On-Brand Devices [TNE]

00850015110061Temporary Resin Based Dental Cement
00850015110054Resin Based Dental Cement

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