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510(k) Data Aggregation

    K Number
    K173965
    Device Name
    Implant Planning Software
    Manufacturer
    Inteware Co. Ltd.
    Date Cleared
    2018-10-26

    (301 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Inteware Co. Ltd. for their "Implant Planning Software." It confirms substantial equivalence but does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria.

    Therefore, I cannot provide the requested information from the text. The document primarily focuses on the FDA's regulatory approval process and general controls, rather than the specific performance metrics and study details of the device.

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