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510(k) Data Aggregation

    K Number
    K232440
    Device Name
    Adravision Perio
    Manufacturer
    Date Cleared
    2023-12-05

    (113 days)

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

    Adra Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Adravision Perio is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The intended users of Adravision Perio are trained professionals including, but not limited to, dental hygienists. The intended patient population of the device is patients living in the United States, who are 22 years old or older, and that do not have any remaining primary teeth. Adra Corporation has not evaluated the performance of the device on primary dentition.
    Device Description
    Adravision Perio is a Software as a Medical Device (SaMD intended to aid dentists in the measurement of mesial and dista bone levels associated with each tooth on bitewing and periapical dental radiographs of permanent teeth in patients 22 years of age or older. The device provides assistance to dentists by suggesting the measurement of interproximal bone levels. The device recommendations are for reference only and the user should review associated radiographs, view annotations and modify annotations if needed. The device is not intended as a replacement for a complete clinician's review or their clinical judgment because users can take into account other relevant information from the image, intraoral exam or patient history.
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