CLEARFIL™ SE BOND 2

GUDID EKUR003272KA1

Value Pack

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

• Primary Device ID: EKUR003272KA1
• NIH Device Record Key: a4795328-e46a-4e8c-a4d2-25bb82772892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ SE BOND 2
• Version Model Number: #3272-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 3
• 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	EKUR003272KA0 [Unit of Use]
HIBCC	EKUR003272KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131432

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 2]

• EKUR003287KA1: Unit Dose Trial Pack
• EKUR003286KA1: Unit Dose Standard Pack
• EKUR003282KA1: PRIMER
• EKUR003281KA1: BOND
• EKUR003275KA1: Trial Pack
• EKUR003272KA1: Value Pack
• EKUR003270KA1: Kit