CLEARFIL™ AP-X PLT

GUDID EKUR001742KA1

A3

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR001742KA1
• NIH Device Record Key: 34645815-86db-4057-8ac6-f6221625ed69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ AP-X PLT
• Version Model Number: #1742-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 20
• 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	EKUR001742KA0 [Unit of Use]
HIBCC	EKUR001742KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023002

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™ AP-X PLT]

• EKUR001755KA1: A2 (Sample)
• EKUR001754KA1: HO
• EKUR001751KA1: XL
• EKUR001746KA1: B3
• EKUR001745KA1: B2
• EKUR001744KA1: A4
• EKUR001743KA1: A3.5
• EKUR001742KA1: A3
• EKUR001741KA1: A2