CLEARFIL™ PHOTO CORE

GUDID EKUR000355KA1

3 Syringes

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: 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