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510(k) Data Aggregation

    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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