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510(k) Data Aggregation

    K Number
    K241681
    Device Name
    Overjet Image Enhancement Assist
    Manufacturer
    Date Cleared
    2024-09-09

    (90 days)

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

    Overjet Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Overjet Image Enhancement Assist is an image processing software that can be used for image enhancement in dental radiographs viewed in the Overjet device platform. It is an optional tool to be used for image quality enhancement. The software improves image quality by: - Reducing Noise: Utilizing a learning-based algorithm for noise reduction in bitewing and periapical images. - Enhancing Contrast and Sharpness: Applying standard, non-learning based techniques to enhance contrast and sharpness for bitewing, periapical, and panoramic images. Raw images will be acquired and reviewed using the dental clinics standard imaging acquisition and viewing software. This device is part of the Overjet platform alone, it is not intended to replace their own diagnostic imaging system.
    Device Description
    Overjet Image Enhancement is a Software as a Medical Device (SaMD) that enhances dental radiographic images within the Overjet Platform, intended for use by dental providers in clinics or hospitals. It supports routine dental images, including bitewing, periapical, and panoramic images, viewed within the Overjet Platform. The software enhances image quality by reducing noise with a learning-based algorithm for bitewing and periapical images, and by improving contrast and sharpness using standard, non-learning based techniques. For panoramic images, standard enhancement techniques improve contrast and sharpness without learning-based noise reduction. The enhancement feature can be toggled on and off by the user within the Overjet Platform. AI predictions for findings such as caries, calculus, etc. are run as specified for each FDA cleared device and are run on unenhanced (original) images only. There is no modification to the output of other FDA cleared Overjet devices when the image enhancement feature is applied.
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    K Number
    K220928
    Device Name
    Overjet Calculus Assist
    Manufacturer
    Date Cleared
    2022-12-16

    (260 days)

    Product Code
    Regulation Number
    892.2070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Overjet Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Overjet Calculus Assist (OCalA) is a radiological automated concurrent-read computer-assisted detection software intended to aid in the detection of interproximal calculus deposits on both bitewing and periapical radiographs. The Overjet Calculus Assist surrounds suspected calculus deposits with a bounding box. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of containing calculus deposits. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.
    Device Description
    Overjet Calculus Assist is a module within the Overjet Platform. The Overjet Calculus Assist (OCalA) software automatically detects interproximal calculus on bitewing and periapical radiographs. It is intended to aid dentists in the detection of calculus. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by professionally trained and licensed dentists.
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