Applicator brush (superfine)

GUDID EKUR001221KA0

KURARAY NORITAKE DENTAL INC.

Dental material application tool, single-use

• Primary Device ID: EKUR001221KA0
• NIH Device Record Key: d47628b1-e1f4-4185-93e9-502c1d22a752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Applicator brush (superfine)
• Version Model Number: #1221-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR001221KA0 [Unit of Use]
HIBCC	EKUR001221KA1 [Primary]

FDA Product Code

• KXR: Applicator, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-03
• Device Publish Date: 2024-08-26

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 ONE: 2024-04-08 SPEED CROWN A1
• EKUR1259731KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A2
• EKUR1259732KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A3
• EKUR1259733KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A3.5
• EKUR1259734KA0 - KATANA™ Zirconia ONE: 2024-04-08 SPEED CROWN A4