Fusion Flo 20009

GUDID D96720009

PREVEST DENPRO LIMITED

Dental composite resin kit

• Primary Device ID: D96720009
• NIH Device Record Key: 9bc55386-6535-452b-b618-a733b2263a4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Flo
• Version Model Number: Combo Pack
• Catalog Number: 20009
• 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	D96720009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231263

FDA Product Code

• EBF: Material, Tooth Shade, 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 Flo]

• D96720009: Combo Pack
• D967200081: Trial Pack
• D96720008: Intro Pack