Noritake Super Porcelain EX-3 n COLOR INTRO POBA KIT

GUDID EKUR1020060KA0

108g

KURARAY NORITAKE DENTAL INC.

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• Primary Device ID: EKUR1020060KA0
• NIH Device Record Key: 01b78805-f017-46d9-9d43-0b02074b83bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noritake Super Porcelain EX-3 n COLOR INTRO POBA KIT
• Version Model Number: 102-0060KA
• 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: true
• 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	EKUR1020060KA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193060

FDA Product Code

• EIH: Powder, Porcelain

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: 2018-07-24
• Device Publish Date: 2017-02-17

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