PANAVIA™ F 2.0

GUDID EKUR000482KA1

Introductory Kit (OPAQUE)

KURARAY NORITAKE DENTAL INC.

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• Primary Device ID: EKUR000482KA1
• NIH Device Record Key: 9faf7495-548a-414b-9948-bb3fbc9e5243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANAVIA™ F 2.0
• Version Model Number: #482-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	EKUR000482KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032455

FDA Product Code

• EMA: Cement, Dental

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 [PANAVIA™ F 2.0]

• EKUR000497KA1: B paste (LIGHT)
• EKUR000496KA1: B paste (OPAQUE)
• EKUR000495KA1: B paste (WHITE)
• EKUR000494KA1: B paste (TC)
• EKUR000493KA1: A paste
• EKUR000492KA1: ED PRIMER Ⅱ Liquid B
• EKUR000491KA1: ED PRIMER Ⅱ Liquid A
• EKUR000490KA1: OXYGUARD Ⅱ
• EKUR000483KA1: Introductory Kit (LIGHT)
• EKUR000482KA1: Introductory Kit (OPAQUE)
• EKUR000481KA1: Introductory Kit (WHITE)
• EKUR000480KA1: Introductory Kit (TC)