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510(k) Data Aggregation

    K Number
    K211537
    Device Name
    QuickAligners
    Manufacturer
    Date Cleared
    2021-10-26

    (161 days)

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

    Oral Image, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Oral Image QuickAligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion. QuickAligners position teeth by way of continuous gentle force.
    Device Description
    The Oral Image QuickAligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial state to a different end state using a softwaregenerated sequence of intermediate states. Based on a clinician's prescribed treatment plan, each aligner in the set is used for the specified period of time to exert gentle force to achieve progressive realignment of the final correction has been achieved. Standard treatment time for each aligner tray is 2-3 weeks, worn by patient for 22 hours per day.
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