TrusFIL Universal Composite Restorative

GUDID 06972220489139

Rizhao HuGe Biomaterials Company, Ltd.

Dental composite resin

• Primary Device ID: 06972220489139
• NIH Device Record Key: f25dea08-2c82-45ea-a952-b2e665ae9d6f
• Commercial Distribution Discontinuation: 2023-11-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TrusFIL Universal Composite Restorative
• Version Model Number: B1-4g
• Company DUNS: 544452689
• Company Name: Rizhao HuGe Biomaterials Company, Ltd.
• 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: false
• 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
GS1	06972220489139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202063

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: 2023-11-10
• Device Publish Date: 2023-11-02

On-Brand Devices [TrusFIL Universal Composite Restorative]

• 06972220489139: B1-4g
• 06972220489085: A1-4g