GEL ETCH

GUDID 00850015110405

DENTAL ETCHING PREPARATORY MATERIAL

TEMREX CORPORATION

Dental etching solution
Primary Device ID00850015110405
NIH Device Record Keycb4a70f0-036a-4df3-83fd-445af9e0df74
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEL ETCH
Version Model Number6580 60GM. BULK SYRINGE
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
GS100850015110405 [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 Date2020-02-20
Device Publish Date2020-02-12

On-Brand Devices [GEL ETCH]

00850015110405DENTAL ETCHING PREPARATORY MATERIAL
00850015110399DENTAL ETCHING PREPARATORY MATERIAL
00850015110382DENTAL ETCHING PREPARATORY MATERIAL
00850015110375DENTAL ETCHING PREPARATORY MATERIAL

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