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.

EKUR1259730KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN A1
EKUR1259731KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN A2
EKUR1259732KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN A3
EKUR1259733KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN A3.5
EKUR1259734KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN A4
EKUR1259735KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN B1
EKUR1259736KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN B2
EKUR1259737KA0 - KATANA™ Zirconia ONE2024-04-08 SPEED CROWN B3

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