GEL ETCH SEMI GEL

GUDID 00850015110412

DENTAL ETCHING PREPARATORY MATERIAL

TEMREX CORPORATION

Dental etching solution
Primary Device ID00850015110412
NIH Device Record Key4197fd56-f66b-4f7b-907f-555ff89cd8c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEL ETCH SEMI GEL
Version Model Number6200 13CC BOTTLE
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
GS100850015110412 [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 SEMI GEL]

00850015110429DENTAL ETCHING PREPARATORY MATERIAL
00850015110412DENTAL ETCHING PREPARATORY MATERIAL

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