Noritake Super Porcelain EX-3 TRIAL KIT NV1120

GUDID EKUR1020400KA0

26g

KURARAY NORITAKE DENTAL INC.

Dental appliance fabrication material, ceramic
Primary Device IDEKUR1020400KA0
NIH Device Record Keyf7e47564-ca32-41dd-a87f-81d28116d387
Commercial Distribution StatusIn Commercial Distribution
Brand NameNoritake Super Porcelain EX-3 TRIAL KIT NV1120
Version Model Number102-0400KA
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 Kittrue
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
HIBCCEKUR1020400KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.