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510(k) Data Aggregation

    K Number
    K180953
    Device Name
    AnyCheck IMT-100
    Manufacturer
    DMS Co., Ltd.
    Date Cleared
    2019-02-20

    (315 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMS Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AnyCheck IMT-100 is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
    Device Description
    The AnyCheck IMT-100 Dental Implant Mobility Measuring Instrument is a system designed to measure dental implant mobility (stability) in the oral cavity and maxillofacial region. The AnyCheck IMT-100 is a portable, handheld instrument to observe non-invasively the fixation stability of an implant at alveolar bone. The implant stability test (iST) is performed using vibration generated by mechanical contacting of a tapping rod. The AnyCheck IMT-100 numerically indicates a scale result of iST. The higher number means better stability of the target implant.
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