CLEARFIL™ Universal Bond

GUDID EKUR003300KA1

Unit Dose Trial

KURARAY NORITAKE DENTAL INC.

Dentine bonding agent/set
Primary Device IDEKUR003300KA1
NIH Device Record Keye60ae1a0-c3ad-421e-909e-fbe6845957be
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARFIL™ Universal Bond
Version Model Number#3300-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
HIBCCEKUR003300KA0 [Unit of Use]
HIBCCEKUR003300KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, 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™ Universal Bond]

EKUR003300KA1Unit Dose Trial
EKUR003293KA1Bottle Value Pack
EKUR003292KA1Bottle Refill
EKUR003291KA1Bottle Trial

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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