CLEARFIL Universal Bond Quick 2

GUDID EKUR004041KA1

Bottle Standard Kit

KURARAY NORITAKE DENTAL INC.

Dentine bonding agent/set
Primary Device IDEKUR004041KA1
NIH Device Record Key6c1fa2c5-550e-4c9c-9f37-29ecfa9c1aac
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARFIL Universal Bond Quick 2
Version Model Number#4041-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
HIBCCEKUR004041KA1 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-06
Device Publish Date2024-02-27

On-Brand Devices [CLEARFIL Universal Bond Quick 2]

EKUR004048KA0Unit Dose Trial
EKUR004047KA1Unit Dose Value Pack
EKUR004046KA1Unit Dose Standard Pack
EKUR004045KA1Bottle Trial
EKUR004044KA1Bottle Value Pack
EKUR004042KA1Bottle Refill
EKUR004041KA1Bottle Standard Kit

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