CLEARFIL™ PHOTO CORE

GUDID EKUR000355KA1

3 Syringes

KURARAY NORITAKE DENTAL INC.

Dental composite resin

• Primary Device ID: EKUR000355KA1
• NIH Device Record Key: f60c0242-8d16-4502-8b4d-37eaff678eb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ PHOTO CORE
• Version Model Number: #355-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 3
• 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	EKUR000355KA0 [Unit of Use]
HIBCC	EKUR000355KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012705

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™ PHOTO CORE]

• EKUR000356KA1: 1 Syringe
• EKUR000355KA1: 3 Syringes