Fusion Core DC Flo 20011

GUDID D96720011

PREVEST DENPRO LIMITED

Dental composite resin kit Dental composite resin kit Dental composite resin kit Dental composite resin kit Dental composite resin kit Dental composite resin kit Dental composite resin kit Dental composite resin kit Dental composite resin kit Dental composite resin kit Dental composite resin kit

• Primary Device ID: D96720011
• NIH Device Record Key: bba438c5-74ba-4956-938d-fcf17976de8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Core DC Flo
• Version Model Number: Intro Pack
• Catalog Number: 20011
• 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	D96720011 [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

Devices Manufactured by PREVEST DENPRO LIMITED

• 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
• D96710018 - Renew Universal: 2024-05-01