CLEARFIL™ SA PRIMER

GUDID EKUR000066KA1

KURARAY NORITAKE DENTAL INC.

Dentine bonding agent/set

• Primary Device ID: EKUR000066KA1
• NIH Device Record Key: 14bbafae-052a-454e-8f0a-ef7faa62bc36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ SA PRIMER
• Version Model Number: #066-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	EKUR000066KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021427

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-17

Devices Manufactured by KURARAY NORITAKE DENTAL INC.

• EKUR1259680KA0 - KATANA™ Zirconia ONE: 2024-11-29 For IMPLANT S A1
• EKUR1259681KA0 - KATANA™ Zirconia ONE: 2024-11-29 For IMPLANT S A2
• EKUR1259682KA0 - KATANA™ Zirconia ONE: 2024-11-29 For IMPLANT S A3
• EKUR1259683KA0 - KATANA™ Zirconia ONE: 2024-11-29 For IMPLANT S A3.5
• EKUR1259684KA0 - KATANA™ Zirconia ONE: 2024-11-29 For IMPLANT S B1
• EKUR1259685KA0 - KATANA™ Zirconia ONE: 2024-11-29 For IMPLANT S B2
• EKUR1259686KA0 - KATANA™ Zirconia ONE: 2024-11-29 For IMPLANT S C1
• EKUR1259687KA0 - KATANA™ Zirconia ONE: 2024-11-29 For IMPLANT S C2