CLEARFIL MAJESTY™ Posterior PLT

GUDID EKUR002701KA1

E3

KURARAY NORITAKE DENTAL INC.

Dental composite resin
Primary Device IDEKUR002701KA1
NIH Device Record Key414b5745-4e3a-4b85-997a-e4db539613dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARFIL MAJESTY™ Posterior PLT
Version Model Number#2701-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
Device Count20
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
HIBCCEKUR002701KA0 [Unit of Use]
HIBCCEKUR002701KA1 [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™ Posterior PLT ]

EKUR002701KA1E3
EKUR002700KA1E2
EKUR002695KA1B2
EKUR002693KA1A3
EKUR002692KA1A2
EKUR002691KA1A1

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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