Orthocem 4000055255

GUDID 07899633826582

Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets.

Dentscare Ltda

Orthodontic bracket adhesive

• Primary Device ID: 07899633826582
• NIH Device Record Key: 133cb542-4ae5-4c09-8701-11cecfee2843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthocem
• Version Model Number: 4g
• Catalog Number: 4000055255
• 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	07899633826582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192682

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: 2020-11-09
• Device Publish Date: 2020-10-30

Devices Manufactured by Dentscare Ltda

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• 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