Disposable brush tips (white)

GUDID EKUR000968KA0

KURARAY NORITAKE DENTAL INC.

Dental material application tool, single-use

• Primary Device ID: EKUR000968KA0
• NIH Device Record Key: 77a7d9cc-04cb-4a49-a946-6647235ad93b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable brush tips (white)
• Version Model Number: #968-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	EKUR000968KA0 [Unit of Use]
HIBCC	EKUR000968KA1 [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: 2025-09-01
• Device Publish Date: 2025-08-22

Devices Manufactured by KURARAY NORITAKE DENTAL INC.

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• 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