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510(k) Data Aggregation

    K Number
    K201104
    Device Name
    AsoAligner
    Date Cleared
    2021-02-26

    (308 days)

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

    Aso International Manila, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AsoAlignerTM is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). AsoAligner™ is intended for minor anterior tooth movement by applying continuously gentle force. AsoAligner™ is for prescription only use.
    Device Description
    AsoAligner™ consists of a series (soft, medium, and hard) of patient-specific transparent thermoplastic removable aligners, intended to be used to replace the traditional lingual/labial orthodontic braces for the treatment of tooth malocclusion in patients with permanent dentition, and by applying continuous gentle force to progressively position the teeth. Each aligner is patient-specific and should be used only by the person for whom the aligners were prescribed. AsoAligner™ is provided non-sterile and can be removed by the patient at any time. During clinical examination to a patient with permanent dentition, a dental health professional determines the appropriateness for prescribing the AsoAligner™ to patient based on an assessment of the patient's teeth. The dental health professional takes an impression of the patient's dentition and sends it together with the treatment plan prescription containing the course of treatment to ASO. The patient's impression is then used to produce a series of dental arch setup models using 3Shape's Ortho Analyzer (K180941) based on the instructions found in the treatment plan prescription. The dental health professional will review and approve, or reject (and request for treatment modifications if rejected) the dental arch setups. The validated dental arch setups are then used as a mold to produce the sequential AsoAligner™. The sequential AsoAligner™ is sent back to the dental health professional who then provides them to the patient, confirming fit and design. The dental health professional monitors the patient's treatment from the moment the first aligner is delivered to when the final aligner is delivered. AsoAligner™ is held in place by applying pressure to the patient's teeth.
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