Applicator brush (fine)

GUDID EKUR001024KA1

KURARAY NORITAKE DENTAL INC.

Dental material application tool, single-use
Primary Device IDEKUR001024KA1
NIH Device Record Key1ced5dff-d361-485f-a14d-b8a03dca0fd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameApplicator brush (fine)
Version Model Number#1024-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKUR001024KA0 [Unit of Use]
HIBCCEKUR001024KA1 [Primary]

FDA Product Code

KXRApplicator, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-03
Device Publish Date2024-08-26

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.