Fusion Core DC Flo and Fusion Bond DC 20027

GUDID D967200270

PREVEST DENPRO LIMITED

Dental composite resin kit

• Primary Device ID: D967200270
• NIH Device Record Key: 26cb00ee-6f9a-4d33-9421-16a8ccdd73d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Core DC Flo and Fusion Bond DC
• Version Model Number: Combo Pack
• Catalog Number: 20027
• 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	D967200270 [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: 2025-02-18
• Device Publish Date: 2025-02-10

Devices Manufactured by PREVEST DENPRO LIMITED

• D967200270 - Fusion Core DC Flo and Fusion Bond DC: 2025-02-18
• D967200270 - Fusion Core DC Flo and Fusion Bond DC: 2025-02-18
• D96710001 - Fusion Bond 7: 2024-05-01
• D96710002 - Fusion Bond 7: 2024-05-01
• D96710003 - Fusion Bond 5: 2024-05-01
• D96710004 - Fusion Bond 5: 2024-05-01
• D96710005 - Fusion Bond DC: 2024-05-01
• D96710016 - Renew MDP: 2024-05-01
• D96710017 - Renew Universal: 2024-05-01