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510(k) Data Aggregation

    K Number
    K173965
    Device Name
    Implant Planning Software
    Manufacturer
    Date Cleared
    2018-10-26

    (301 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inteware Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Implant Planning is a software package specifically designed and developed to enable dentists to plan and perform virtual implant surgery prior to actual surgery. Implant Planning supports surgical planning for fully or partially edentulous patient's case.
    Device Description
    Implant Planning is a software package specifically designed and developed to enable dentists to plan and perform virtual implant surgery prior to actual surgery.
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