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510(k) Data Aggregation

    K Number
    K193130
    Device Name
    MVP Aligner System
    Manufacturer
    Date Cleared
    2020-08-07

    (269 days)

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

    MVP Aligners, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MVP Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The MVP Aligners position teeth by way of continuous gentle force.
    Device Description
    The MVP Aligner system is a prescription (Rx) device comprised of a series of dentist prescribed clear, biocompatible, plastic shells that fit over the teeth designed to incrementally improve malocclusion by providing progressive force and moving patient dentition from an initial condition to a preferred corrected condition. After a scan or physical impression of the patient's teeth is taken by or under the direct supervision of the patient's orthodontically trained dentist, each aligner in the sequential set is created by a trained technician utilizing Ortho System software (K180941) according to the orthodontic screening and tooth movement recommendations provided by the same prescribing orthodontically trained dentist. The recommendations are patient specific and can only be relied upon for an individual patient for whom the device is prescribed. Furthermore, the orthodontically trained dentist reviews and approves the model scheme before the molds are produced. Once approved, the trays which are formed of clear, thin, thermoformed plastic are fabricated. The indirect fabrication process involves a 3D print of a plastic model representing the patient specific upper and lower dentition of the patient's jaw. The models are cured. Biocompatible plastic sheets are thermoformed over the cured models with pressure and heat, marked with a patient identifier on the occlusal surface, and trimmed in a 5-axis CNC machine. The aligner containing an individualized trim line is polished, cleaned, sorted and packaged with a UDI. MVP Aligners are provided non-sterile and are completely removable by the patient. Once approved, the trays are sent back to the orthodontically trained dentist who then provides them to the patient, in sequential stages confirming fit and design. The orthodontically trained dentist monitors treatment from the delivery of the first to final aligner.
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