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510(k) Data Aggregation

    K Number
    K230144
    Device Name
    Denti.AI Detect
    Manufacturer
    Denti.AI Technology, Inc.
    Date Cleared
    2023-10-06

    (261 days)

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

    Denti.AI Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Denti. Al Detect is a Computer-Assisted Detection (CADe) software device intended to be used by dental professionals. comprising dentists and dental specialists, while reading extraoral and intraoral 2D dental radiographs. The device aims to assist in detecting and highlighting uncategorized regions of interest (ROIs) within the teeth area, which include cares and periapical radiolucency, as a second reader. The device is also intended to aid in the measurements of mesial and distal bone levels associated with each tooth. The device is aimed to be used with images from the patients of 22 years age and older without remaining primary dentition. The device is not intended to replace a complete clinical judgment that considers other relevant information from the image or patient history.
    Device Description
    Denti.AI Detect is a prescription use Computer-Assisted Detection (CADe) device aimed to assist dentists and dental specialists in detecting and highlighting regions of interest (ROIs) within the teeth area, which include caries and periapical radiolucency. The device is also intended to aid in the measurements of medial and distal bone levels associated with each tooth.
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