ALLOY PRIMER

GUDID EKUR000064KA1

KURARAY NORITAKE DENTAL INC.

Dental prosthesis priming agent
Primary Device IDEKUR000064KA1
NIH Device Record Key2e5318ec-9d62-4085-9a58-5631cb958074
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLOY PRIMER
Version Model Number#064-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
HIBCCEKUR000064KA1 [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 Number4
Public Version Date2018-07-24
Device Publish Date2017-02-17

Devices Manufactured by KURARAY NORITAKE DENTAL INC.

EKUR1259680KA0 - KATANA™ Zirconia ONE2024-11-29 For IMPLANT S A1
EKUR1259681KA0 - KATANA™ Zirconia ONE2024-11-29 For IMPLANT S A2
EKUR1259682KA0 - KATANA™ Zirconia ONE2024-11-29 For IMPLANT S A3
EKUR1259683KA0 - KATANA™ Zirconia ONE2024-11-29 For IMPLANT S A3.5
EKUR1259684KA0 - KATANA™ Zirconia ONE2024-11-29 For IMPLANT S B1
EKUR1259685KA0 - KATANA™ Zirconia ONE2024-11-29 For IMPLANT S B2
EKUR1259686KA0 - KATANA™ Zirconia ONE2024-11-29 For IMPLANT S C1
EKUR1259687KA0 - KATANA™ Zirconia ONE2024-11-29 For IMPLANT S C2

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