CLEARFIL MAJESTY™ IC Bulk

GUDID EKUR004235KA1

Dispensing tip cap

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR004235KA1
• NIH Device Record Key: 242f6a4b-0f30-4a28-bf72-13d28c74fad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL MAJESTY™ IC Bulk
• Version Model Number: #4235-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 10
• 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	EKUR004235KA0 [Unit of Use]
HIBCC	EKUR004235KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182430

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [CLEARFIL MAJESTY™ IC Bulk]

• EKUR004235KA1: Dispensing tip cap
• EKUR004234KA1: Dispensing tip set
• EKUR004232KA1: TRIAL (U)
• EKUR004231KA1: U