Fusion Bond 7 10001

GUDID D96710001

PREVEST DENPRO LIMITED

Dental acrylic resin kit

• Primary Device ID: D96710001
• NIH Device Record Key: 71334b26-37c9-4d05-af62-d2cdad38cd4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Bond 7
• Version Model Number: Intro Pack
• Catalog Number: 10001
• 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	D96710001 [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