ALLOY PRIMER

GUDID EKUR000064KA1

KURARAY NORITAKE DENTAL INC.

Dental prosthesis priming agent

• Primary Device ID: EKUR000064KA1
• NIH Device Record Key: 2e5318ec-9d62-4085-9a58-5631cb958074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLOY PRIMER
• Version Model Number: #064-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKUR000064KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012436

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2017-02-17

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