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510(k) Data Aggregation

    K Number
    K210652
    Device Name
    6MS Invisible Aligner
    Manufacturer
    Date Cleared
    2021-06-02

    (90 days)

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

    SMS OPCO, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    6MS Invisible Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The 6MS Invisible Aligner positions teeth by way of continuous gentle force.
    Device Description
    6MS Invisible Aligner consists of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane-polyester composite. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state. This occurs through forces applied by the appliance to the teeth over time until final correction, according to the dental clinician's prescription has been achieved. A dental clinician prescribes the 6MS Invisible Aligner based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are taken, after which the clinician determine course of treatment with the system. The clinician completes a prescription form using standard dental software used for tooth alignment. The series of plastic aligner trays are designed according to commercially available dental software for planning the tooth alignments. After the digital plan is developed and approved by the prescribing dental clinician, SMS OPCO produces the aligner trays. The customized aligner trays are then provided to the dental clinician who distributes them to the patient assuring fit and function.
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