Fusion Flo SE 20008-4

GUDID D967200084

PREVEST DENPRO LIMITED

Dental composite resin kit

• Primary Device ID: D967200084
• NIH Device Record Key: 6f7a7312-9c44-40cd-b17e-43bb4bb2d782
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Flo SE
• Version Model Number: Intro Pack Bag
• Catalog Number: 20008-4
• 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	D967200084 [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 SE]

• D967200085: Intro Pack Box
• D967200084: Intro Pack Bag
• D967200083: Trial Pack