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510(k) Data Aggregation

    K Number
    K113404
    Device Name
    DENTAL 3D PLANNING SOFTWARE
    Manufacturer
    SYMBYO DENTAL, LLC
    Date Cleared
    2011-12-06

    (18 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
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    Applicant Name (Manufacturer) :

    SYMBYO DENTAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPS is prescription use software used by dentists and dental lab technicians for the visualization and image segmentation of DICOM data from medical scanners such as CT. The software aids the user in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants.
    Device Description
    IPS is a Dental 3D Planning Software that aids dentists and dental lab technicians in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants. The data used for planning the treatment course is obtained from radiological devices (e.g., CT) complying with DICOM format. IPS provides dentists with various visualization and measurement tools which facilitate in generating dental panoramic view, segmenting of the dental anatomical structures and measuring bone density and distance between the dental implants.
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