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    K Number
    K172765
    Device Name
    Smart Moves Complete
    Manufacturer
    Great Lakes Orthodontics Ltd
    Date Cleared
    2018-06-01

    (261 days)

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

    Great Lakes Orthodontics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.
    Device Description
    Smart Moves Complete consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners). The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. Smart Moves Complete is intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.
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