CLEARFIL MAJESTY™ Flow

GUDID EKUR002612KA1

A3

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR002612KA1
• NIH Device Record Key: 0e7991fe-a92c-4337-9f2a-ceecf16273aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL MAJESTY™ Flow
• Version Model Number: #2612-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	EKUR002612KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063593

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™ Flow ]

• EKUR02611KAS1: A2 Sample
• EKUR002635KA1: BL2
• EKUR002632KA1: OA3
• EKUR002621KA1: Cv
• EKUR002620KA1: E2
• EKUR002619KA1: D3
• EKUR002618KA1: C3
• EKUR002616KA1: B2
• EKUR002615KA1: B1
• EKUR002613KA1: A3.5
• EKUR002612KA1: A3
• EKUR002611KA1: A2
• EKUR002610KA1: A1
• EKUR001015KA1: Needle tip