CLEARFIL MAJESTY™ ES Flow Universal

GUDID EKUR004620KA1

Super Low (U)

KURARAY NORITAKE DENTAL INC.

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• Primary Device ID: EKUR004620KA1
• NIH Device Record Key: 15175143-0c3e-46d2-a692-5d69f490e547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL MAJESTY™ ES Flow Universal
• Version Model Number: #4620-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	EKUR004620KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-23
• Device Publish Date: 2024-02-15

On-Brand Devices [CLEARFIL MAJESTY™ ES Flow Universal]

• EKUR004623KA1: Super Low (UD) TRIAL
• EKUR004622KA1: Super Low (U) TRIAL
• EKUR004621KA1: Super Low (UD)
• EKUR004620KA1: Super Low (U)