CLEARFIL™ Universal Bond

GUDID EKUR003300KA1

Unit Dose Trial

KURARAY NORITAKE DENTAL INC.

Dentine bonding agent/set

• Primary Device ID: EKUR003300KA1
• NIH Device Record Key: e60ae1a0-c3ad-421e-909e-fbe6845957be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ Universal Bond
• Version Model Number: #3300-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 5
• 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: true
• 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	EKUR003300KA0 [Unit of Use]
HIBCC	EKUR003300KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132450

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™ Universal Bond]

• EKUR003300KA1: Unit Dose Trial
• EKUR003293KA1: Bottle Value Pack
• EKUR003292KA1: Bottle Refill
• EKUR003291KA1: Bottle Trial