CLEARFIL MAJESTY™ IC

GUDID EKUR003879KA1

C2

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR003879KA1
• NIH Device Record Key: 49150546-1ab6-4a46-b1ee-8bf7d201395d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL MAJESTY™ IC
• Version Model Number: #3879-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	EKUR003879KA1 [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]

• EKUR003892KA1: Dispensing tip cap
• EKUR003891KA1: Dispensing tip set
• EKUR003880KA1: W
• EKUR003879KA1: C2
• EKUR003878KA1: B2
• EKUR003877KA1: B1
• EKUR003875KA1: A4
• EKUR003874KA1: A3.5
• EKUR003873KA1: A3
• EKUR003872KA1: A2
• EKUR003871KA1: A1