Vittra APS Unique Flow 4000056627

GUDID 07899633835232

Vittra APS Unique Flow is a light-curing composite of low viscosity, with a single shade for all dental shades, suitable for minimally invasive cavity preparations, base/liner and minor repairs.

Dentscare Ltda

Dental composite resin

• Primary Device ID: 07899633835232
• NIH Device Record Key: 0a13b08b-0ca8-4f84-8409-70b2a945e062
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vittra APS Unique Flow
• Version Model Number: 2g
• Catalog Number: 4000056627
• Company DUNS: 898067533
• Company Name: Dentscare Ltda
• 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
GS1	07899633835232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232994

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: 2024-12-04
• Device Publish Date: 2024-11-26

Devices Manufactured by Dentscare Ltda

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• 07899633835263 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835270 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835287 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835294 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835300 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental
• 07899633835317 - PrimmaArt: 2025-04-16 PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental