CLEARFIL MAJESTY™ ES Flow

GUDID EKUR003307KA1

B1

KURARAY NORITAKE DENTAL INC.

Dental composite resin
Primary Device IDEKUR003307KA1
NIH Device Record Keydbfbe78a-f5ab-4ce6-9f1d-8ac2778e28af
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARFIL MAJESTY™ ES Flow
Version Model Number#3307-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
HIBCCEKUR003307KA1 [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

On-Brand Devices [CLEARFIL MAJESTY™ ES Flow]

EKUR003331KA1Needle tip (N)
EKUR003317KA1TRIAL (A2)
EKUR003312KA1W
EKUR003309KA1XW
EKUR003308KA1B2
EKUR003307KA1B1
EKUR003306KA1KA6
EKUR003305KA1A4
EKUR003304KA1A3.5
EKUR003303KA1A3
EKUR003302KA1A2
EKUR003301KA1A1

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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