CLEARFIL MAJESTY™ ES Flow Universal

GUDID EKUR004620KA1

Super Low (U)

KURARAY NORITAKE DENTAL INC.

Dental composite resin
Primary Device IDEKUR004620KA1
NIH Device Record Key15175143-0c3e-46d2-a692-5d69f490e547
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARFIL MAJESTY™ ES Flow Universal
Version Model Number#4620-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
HIBCCEKUR004620KA1 [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 Date2024-02-23
Device Publish Date2024-02-15

On-Brand Devices [CLEARFIL MAJESTY™ ES Flow Universal]

EKUR004623KA1Super Low (UD) TRIAL
EKUR004622KA1Super Low (U) TRIAL
EKUR004621KA1Super Low (UD)
EKUR004620KA1Super Low (U)

Trademark Results [CLEARFIL MAJESTY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARFIL MAJESTY
CLEARFIL MAJESTY
76650323 3333147 Live/Registered
KURARAY CO., LTD.
2005-11-15

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