SURFACE COAT™

GUDID EKUR000263KA1

KURARAY NORITAKE DENTAL INC.

Dental unfilled resin sealant/coating

• Primary Device ID: EKUR000263KA1
• NIH Device Record Key: cb6039d4-4515-4205-8439-5a333e8d5e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURFACE COAT™
• Version Model Number: #263-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	EKUR000263KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063228

FDA Product Code

• EBD: Coating, Filling Material, 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

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