Fusion Bond 7 10002

GUDID D96710002

PREVEST DENPRO LIMITED

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• Primary Device ID: D96710002
• NIH Device Record Key: 08ca171b-6e16-4c5d-afb2-c49e9cced4b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Bond 7
• Version Model Number: Economy Pack
• Catalog Number: 10002
• 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	D96710002 [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 7 ]

• D96710002: Economy Pack
• D96710001: Intro Pack