Applicator brush (superfine)

GUDID EKUR001221KA0

KURARAY NORITAKE DENTAL INC.

Dental material application tool, single-use
Primary Device IDEKUR001221KA0
NIH Device Record Keyd47628b1-e1f4-4185-93e9-502c1d22a752
Commercial Distribution StatusIn Commercial Distribution
Brand NameApplicator brush (superfine)
Version Model Number#1221-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
HIBCCEKUR001221KA0 [Unit of Use]
HIBCCEKUR001221KA1 [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.

EKUR001024KA1 - Applicator brush (fine)2024-09-03
EKUR001025KA0 - Applicator brush (endo)2024-09-03
EKUR001221KA0 - Applicator brush (superfine)2024-09-03
EKUR001221KA0 - Applicator brush (superfine)2024-09-03
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

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