CLEARFIL™ TRI-S BOND PLUS Unit Dose

GUDID EKUR002899KA1

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: EKUR002899KA1
• NIH Device Record Key: 91d9af9c-4656-48c2-bc44-ec0d965501f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ TRI-S BOND PLUS Unit Dose
• Version Model Number: #2899-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 100
• 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	EKUR002899KA0 [Unit of Use]
HIBCC	EKUR002899KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111975

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™ TRI-S BOND PLUS Unit Dose]

• EKUR002900KA1: Introductory Pack
• EKUR002899KA1: Value Pack
• EKUR002898KA1: Standard Pack