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510(k) Data Aggregation

    K Number
    K173738
    Device Name
    Archworx
    Manufacturer
    Utah Medical Products and Services
    Date Cleared
    2021-02-26

    (1178 days)

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

    Utah Medical Products and Services

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.
    Device Description
    Devices are intraoral thermoformed plastic aligner trays for tooth malocclusion correction.
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