PANAVIA™ Veneer LC

GUDID EKUR004513KA0

Applicator tip (16G)

KURARAY NORITAKE DENTAL INC.

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• Primary Device ID: EKUR004513KA0
• NIH Device Record Key: e3257717-4fe1-47b5-bded-7056c211cfce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANAVIA™ Veneer LC
• Version Model Number: #4513-KA
• Company DUNS: 697119498
• Company Name: KURARAY NORITAKE DENTAL INC.
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	EKUR004513KA0 [Unit of Use]
HIBCC	EKUR004513KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210504

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-15
• Device Publish Date: 2021-11-05

On-Brand Devices [PANAVIA™ Veneer LC ]

• EKUR004513KA0: Applicator tip (16G)
• EKUR004510KA1: Trial (Clear)
• EKUR004508KA1: White
• EKUR004507KA1: Brown (A4)
• EKUR004506KA1: Clear
• EKUR004505KA1: Universal (A2)
• EKUR004502KA1: Introductory Kit
• EKUR004511KA1: Paste Trial (Soft White (B0.5))
• EKUR004504KA1: Paste (Soft White (B0.5))