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510(k) Data Aggregation

    K Number
    K040224
    Device Name
    CADIMPLANT
    Manufacturer
    PRAXIM INC
    Date Cleared
    2004-04-06

    (64 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRAXIM INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CADImplant is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.
    Device Description
    The CADImplant software is specifically designed for use in dental implant procedures. It allows the dentist to locate dental implants on three planes (axial, sagittal and frontal) on a pre-treatment CT scan in real-time. Additionally, the software allows for the patient's prosthetic template to be pre-drilled according to the planning.
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