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510(k) Data Aggregation

    K Number
    K220903
    Device Name
    WebCeph
    Date Cleared
    2022-08-17

    (142 days)

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

    AssembleCircle Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Web Ceph is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO (Visual Treatment Objective) and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for the use of patients above 7 years old.
    Device Description
    WebCeph is a 2D orthodontic analysis program. It manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualized treatment objective) and STO (surgical treatment objective). The analyzed results are saved in chart format so that the users can easily store and track the treatment and records of each patient. This device is designed to provide a simple and straightforward user interface. WebCeph is used for registering orthodontic medical images and managing the patient information through the features of making schedules and managing patient appointments. This software receives image files (JPG, BMP, PNG) as input source and enables the users to easily calibrate the size of the image or arrange multiple film/photo images. The feature of anatomical landmark detection support more accurate and easier tracing by enabling the user precisely to adjust the position of the detected landmarks. After image alignment, orthodontic treatment simulation and Maxillo-facial surgical planning simulation can be performed. The Morphing feature enables the dentist user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the dentist user to establish a treatment plan by comparing photos before and after the treatment. Cephalometric analysis results are provided as a report. The report can be saved in PDF file or Excel file format. For the evaluation of treatment progress, the software automatically superimposes the lateral cephalographic image. This software provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays the changes visually due to the treatment and the Gallery feature plays a slide show with multiple images of patients.
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