K-ETCHANT GEL

GUDID EKUR000013KA1

KURARAY NORITAKE DENTAL INC.

Dental etching solution
Primary Device IDEKUR000013KA1
NIH Device Record Keyd0cbdd0e-9c1f-44aa-806a-81d5becc6857
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-ETCHANT GEL
Version Model Number#013-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
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
HIBCCEKUR000013KA1 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-17

Devices Manufactured by KURARAY NORITAKE DENTAL INC.

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