CLEARFIL™ AP-X

GUDID EKUR001729KA1

C3

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR001729KA1
• NIH Device Record Key: 28a5e89d-e08f-481e-b9a7-8dc6c4e2905e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ AP-X
• Version Model Number: #1729-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	EKUR001729KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012740

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 ]

• EKUR001734KA1: HO
• EKUR001733KA1: CL
• EKUR001732KA1: C1
• EKUR001731KA1: XL
• EKUR001730KA1: C4
• EKUR001729KA1: C3
• EKUR001728KA1: C2
• EKUR001727KA1: B4
• EKUR001726KA1: B3
• EKUR001725KA1: B2
• EKUR001724KA1: A4
• EKUR001723KA1: A3.5
• EKUR001722KA1: A3
• EKUR001721KA1: A2