Applicator brush (endo)

GUDID EKUR001025KA0

KURARAY NORITAKE DENTAL INC.

Surgical retraction system mounting frame, reusable

• Primary Device ID: EKUR001025KA0
• NIH Device Record Key: 0228e88b-8c00-45b1-8cbd-d7d87d7d3c5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Applicator brush (endo)
• Version Model Number: #1025-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	EKUR001025KA0 [Unit of Use]
HIBCC	EKUR001025KA1 [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.

• EKUR1259755KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 A1 C
• EKUR1259775KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 A2 C
• EKUR1259795KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 B1 C
• EKUR1259805KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 C1 C
• EKUR1259815KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 D2 C
• EKUR1259825KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 EW0 C
• EKUR1259845KA0 - KATANA™ Zirconia: 2025-09-09 YML T26 NW C
• EKUR000967KA0 - Disposable brush tips (black): 2025-09-01