CLEARFIL™ SE BOND

GUDID EKUR001982KA1

PRIMER

KURARAY NORITAKE DENTAL INC.

Dentine bonding agent/set

• Primary Device ID: EKUR001982KA1
• NIH Device Record Key: b8085a7a-1d7f-4fc7-b9c0-a6f19d43f0cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ SE BOND
• Version Model Number: #1982-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	EKUR001982KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012442

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

On-Brand Devices [CLEARFIL™ SE BOND]

• EKUR001982KA1: PRIMER
• EKUR001981KA1: BOND
• EKUR001975KA1: Introductory Kit
• EKUR001972KA1: Value Kit
• EKUR001970KA1: Kit