CLEARFIL™ SE Protect

GUDID EKUR002870KA1

Kit

KURARAY NORITAKE DENTAL INC.

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• Primary Device ID: EKUR002870KA1
• NIH Device Record Key: ccb07b4c-05aa-4639-a056-982f87c96fea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARFIL™ SE Protect
• Version Model Number: #2870-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	EKUR002870KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033938

FDA Product Code

• LBH: Varnish, Cavity

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™ SE Protect]

• EKUR002887KA1: Unit Dose Trial Pack
• EKUR002886KA1: Unit Dose Standard Pack
• EKUR002882KA1: PRIMER
• EKUR002881KA1: BOND
• EKUR002875KA1: Introductory Kit
• EKUR002872KA1: Value Kit
• EKUR002870KA1: Kit