CLEARFIL™ DC BOND

GUDID EKUR002511KA1

Introductory Set

KURARAY NORITAKE DENTAL INC.

Dentine bonding agent/set

• Primary Device ID: EKUR002511KA1
• NIH Device Record Key: f6984ae4-1e78-46ef-9c7b-af932fb0fd4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ DC BOND
• Version Model Number: #2511-KA
• 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: 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	EKUR002511KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062382

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™ DC BOND]

• EKUR002513KA1: BOND Liquid B
• EKUR002512KA1: BOND Liquid A
• EKUR002511KA1: Introductory Set
• EKUR002510KA1: Kit