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510(k) Data Aggregation

    K Number
    K192069
    Device Name
    Aerodentis System
    Manufacturer
    Date Cleared
    2020-05-06

    (279 days)

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

    Dror Orthodesign

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aerodentis System is indicated for use in movement and alignment of teeth during orthodontic treatment of malocclusion.
    Device Description
    The Aerodentis System is an orthodontic system intended to adjust the patient's teeth through movement from their initial position to the desired position as a result of pulsatile mechanical force. The device is designed to achieve orthodontic tooth movement over a period of approximately 10 hours per day (typically at night). The device is suitable for patients with full complement of permanent teeth in need of upper, lower or combined jaw treatments. The system is composed of two primary components: A custom-made, latex-free, plastic dental mouthpiece is inserted and worn by the patient according to a customized treatment prescription specified by the dental practitioner. The Personal Treatment Controller (PTC), which provides compressed air to the mouthpiece via a polyurethane tube.
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