CLEARFIL Universal Bond Quick 2

GUDID EKUR004048KA0

Unit Dose Trial

KURARAY NORITAKE DENTAL INC.

Dentine bonding agent/set

• Primary Device ID: EKUR004048KA0
• NIH Device Record Key: b2914586-3f03-46a0-8e51-fb2dd35937c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL Universal Bond Quick 2
• Version Model Number: #4048-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	EKUR004048KA0 [Unit of Use]
HIBCC	EKUR004048KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231039

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: 2024-03-06
• Device Publish Date: 2024-02-27

On-Brand Devices [CLEARFIL Universal Bond Quick 2]

• EKUR004048KA0: Unit Dose Trial
• EKUR004047KA1: Unit Dose Value Pack
• EKUR004046KA1: Unit Dose Standard Pack
• EKUR004045KA1: Bottle Trial
• EKUR004044KA1: Bottle Value Pack
• EKUR004042KA1: Bottle Refill
• EKUR004041KA1: Bottle Standard Kit