CLEARFIL™ AP-X PLT

GUDID EKUR001754KA1

HO

KURARAY NORITAKE DENTAL INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: EKUR001754KA1
• NIH Device Record Key: 11b0a8dc-0cdb-45e5-a67c-4e7d71ec89cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ AP-X PLT
• Version Model Number: #1754-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	EKUR001754KA0 [Unit of Use]
HIBCC	EKUR001754KA1 [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