Esthetic Colorant

GUDID EKUR1270105KA0

ORANGE 12ML

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic
Primary Device IDEKUR1270105KA0
NIH Device Record Key91f4c47a-4173-447a-bfad-8843bb8c3a7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsthetic Colorant
Version Model Number127-0105KA
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
HIBCCEKUR1270105KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-08
Device Publish Date2022-10-31

On-Brand Devices [Esthetic Colorant]

EKUR2270019KA0LIQUID BRUSH PEN
EKUR1270165KA0OPAQUE 12ML
EKUR1270155KA0WHITE 12ML
EKUR1270145KA0PINK 12ML
EKUR1270135KA0VIOLET 12ML
EKUR1270125KA0BLUE 12ML
EKUR1270115KA0GRAY 12ML
EKUR1270105KA0ORANGE 12ML
EKUR1270095KA0BROWN 12ML
EKUR1270085KA0D PLUS 12ML
EKUR1270075KA0C PLUS 12ML
EKUR1270065KA0B PLUS 12ML
EKUR1270055KA0A PLUS 12ML
EKUR1270010KA0BASIC KIT 144ML

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