CLEARFIL Universal Bond Quick

GUDID EKUR003569AL1

Bonding Agent Kit

KURARAY NORITAKE DENTAL INC.

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

• Primary Device ID: EKUR003569AL1
• NIH Device Record Key: 5cdae31c-edb1-45f1-be19-2ad71c5122cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL Universal Bond Quick
• Version Model Number: #3569-AL
• 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: 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	EKUR003569AL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161042

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [CLEARFIL Universal Bond Quick]

• EKUR003579KA1: Unit Dose Trial
• EKUR003578KA1: Unit Dose Value Pack
• EKUR003577KA1: Unit Dose Standard Pack
• EKUR003575KA1: Bottle Trial
• EKUR003574KA1: Bottle Value Pack
• EKUR003572KA1: Bottle Refill
• EKUR003571KA1: Bottle Standard Kit
• EKUR003569AL1: Bonding Agent Kit