CLEARFIL MAJESTY™ ES Flow

GUDID EKUR003309KA1

XW

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR003309KA1
• NIH Device Record Key: 1db78b06-b517-43ac-b1b3-8d28e8494b53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL MAJESTY™ ES Flow
• Version Model Number: #3309-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	EKUR003309KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130371
• Premarket Notification: K191980

FDA Product Code

• EBF: Material, Tooth Shade, 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 MAJESTY™ ES Flow]

• EKUR003331KA1: Needle tip (N)
• EKUR003317KA1: TRIAL (A2)
• EKUR003312KA1: W
• EKUR003309KA1: XW
• EKUR003308KA1: B2
• EKUR003307KA1: B1
• EKUR003306KA1: KA6
• EKUR003305KA1: A4
• EKUR003304KA1: A3.5
• EKUR003303KA1: A3
• EKUR003302KA1: A2
• EKUR003301KA1: A1