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510(k) Data Aggregation

    K Number
    K203442
    Device Name
    Inbrace Orthodontic System
    Date Cleared
    2021-02-19

    (88 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Swift Health Systems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Inbrace Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using appliances individualized for the orthodontic patient.
    Device Description
    The Inbrace Orthodontic System is a treatment planning software and orthodontic appliance system designed to be affixed to the lingual side of the teeth to correct malocclusions in orthodontic patients. The Inbrace software creates a 3-dimentional (3D) model of the patient 's dentition based on the digital scans of the patient's dentition provided by the orthodontist. The Inbrace technicians use this computer model to determine the placement of the brackets to achieve the intended repositioning of the teeth (ideal occlusion). The model is reviewed and approved by the orthodontist prior to fabrication of the actual orthodontic appliances comprising of metal brackets, patient-specific programmed multiloop arch wires, and patient-specific bracket placement trays (indirect bonding trays) used to affix the brackets in position on the patient teeth. The brackets are assembled into the indirect bonding trays and bonded with a commercially available dental adhesive.
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