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510(k) Data Aggregation

    K Number
    K202691
    Device Name
    Ortholock Anchorage Devices
    Manufacturer
    Craniofacial Technologies, Inc.
    Date Cleared
    2022-04-28

    (590 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Craniofacial Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortholock Anchorage Devices are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
    Device Description
    The Ortholock anchorage device is an implantable self-drilling orthodontic microimplant intended to provide a temporary fixed anchorage point to facilitate orthodontic treatment. The device interacts with an appliance accessory, which includes two insertion locations for Ortholock and a tube for the attachment of general orthodontic appliances. The devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified.
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