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510(k) Data Aggregation

    K Number
    K213263
    Device Name
    OnyxCeph
    Manufacturer
    Image Instruments GmbH
    Date Cleared
    2023-01-04

    (461 days)

    Product Code
    LLZ,PNN
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K171634,K192475,K053010
    Why did this record match?
    Device Name :

    OnyxCeph

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    OnyxCeph3™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

    The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.

    Device Description

    OnyxCeph3™ dental aligner software device is designed for the simulation and planning of orthodontic and maxillofacial surgical combination treatments, based on virtual models and CT / DVT volume data. OnyxCeph3™ is a software device that includes both 3D and 2D versions both suitable for dental facilities to use for orthodontic treatments.

    AI/ML Overview

    The provided text is a K213263 510(k) summary for the OnyxCeph3™ device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document states that "Clinical testing has not been included and is not required to demonstrate substantial equivalence."

    Therefore, I cannot provide the requested information from the given text.

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