PrimmaArt 4000056649

GUDID 07899633835478

PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary restorations for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.

Dentscare Ltda

Dental composite resin

• Primary Device ID: 07899633835478
• NIH Device Record Key: 459aa6b0-145b-4e9d-8667-ca4862ac3b5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrimmaArt
• Version Model Number: CART 75G 5UN
• Catalog Number: 4000056649
• 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	07899633835478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231859

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2025-04-16
• Device Publish Date: 2025-04-08

On-Brand Devices [ PrimmaArt]

• 07899633835492: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835485: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835478: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835461: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835331: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835324: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835317: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835300: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835294: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835287: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835270: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835263: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835256: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r
• 07899633835249: PrimmaArt is a self-curing composite that is highly efficient for the fabrication of temporary r