CLEARFIL™ PHOTO CORE

GUDID EKUR000355KA1

3 Syringes

KURARAY NORITAKE DENTAL INC.

Dental composite resin
Primary Device IDEKUR000355KA1
NIH Device Record Keyf60c0242-8d16-4502-8b4d-37eaff678eb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARFIL™ PHOTO CORE
Version Model Number#355-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
Device Count3
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
HIBCCEKUR000355KA0 [Unit of Use]
HIBCCEKUR000355KA1 [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™ PHOTO CORE]

EKUR000356KA11 Syringe
EKUR000355KA13 Syringes

Trademark Results [CLEARFIL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARFIL
CLEARFIL
73323699 1216331 Live/Registered
Kuraray Co. Ltd.
1981-08-14
CLEARFIL
CLEARFIL
72234774 0820167 Dead/Expired
SCHWARZ SERVICES INTERNATIONAL LIMITED
1965-12-16

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