Ortho Bite 4000019365

GUDID 07899633815982

Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment. The product is colored in order to facilitate its identification during application and removal.

Dentscare Ltda

Orthodontic bracket adhesive

• Primary Device ID: 07899633815982
• NIH Device Record Key: 2db04e89-5d71-44ad-9ac2-15577334f34a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ortho Bite
• Version Model Number: 4g
• Catalog Number: 4000019365
• 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	07899633815982 [Primary]

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: 2022-05-05
• Device Publish Date: 2022-04-27

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