Fusion Bond 5 10003

GUDID D96710003

PREVEST DENPRO LIMITED

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• Primary Device ID: D96710003
• NIH Device Record Key: 9e38233a-51a3-4aa2-8b9f-41720ba8d55b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Bond 5
• Version Model Number: Intro Pack
• Catalog Number: 10003
• Company DUNS: 859546940
• Company Name: PREVEST DENPRO LIMITED
• 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: true
• 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	D96710003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231696

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [Fusion Bond 5]

• D96710004: Economy Pack
• D96710003: Intro Pack