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510(k) Data Aggregation

    K Number
    K242437
    Device Name
    Smile Dx®
    Manufacturer
    Cube Click, Inc.
    Date Cleared
    2025-05-14

    (271 days)

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

    Cube Click, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smile Dx® is a computer-assisted detection (CADe) software designed to aid dentists in the review of digital files of bitewing and periapical radiographs of permanent teeth. It is intended to aid in the detection and segmentation of suspected dental findings which include: caries, periapical radiolucencies (PARL), restorations, and dental anatomy. Smile Dx® is also intended to aid dentists in the measurement (in millimeter and percentage measurements) of mesial and distal bone levels associated with each tooth. 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, patient history, and actual in vivo clinical assessment. Smile Dx® supports both digital and phosphor sensors.
    Device Description
    Smile Dx® is a computer assisted detection (CADe) device indicated for use by licensed dentists as an aid in their assessment of bitewing and periapical radiographs of secondary dentition in adult patients. Smile Dx® utilizes machine learning to produce annotations for the following findings: - Caries - Periapical radiolucencies - Bone level measurements (mesial and distal) - Normal anatomy (enamel, dentin, pulp, and bone) - Restorations
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