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510(k) Data Aggregation

    K Number
    K153091
    Device Name
    IMPLANT 3D
    Manufacturer
    Date Cleared
    2016-02-25

    (122 days)

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

    Media Lab S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Implant 3D is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CAT scanner. It is also intended as pre-planning software for dental implant placement.
    Device Description
    Implant 3D is a software that allows to perform three-dimensional implant simulation directly on the PC. It enables to simulate the position of the implants in bi-dimensional and three-dimensional models. It also consent to identify the mandibular canal and to draw overviews and sections of the bone mode. Implant 3D enables to view the three dimensional bone model with the possibility to provide a qualitative indication of bone density. Implant 3D generates the overview, the sections and the three-dimensional bone model by reading the axial images.
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