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510(k) Data Aggregation

    K Number
    K210187
    Device Name
    Overjet Dental Assist
    Manufacturer
    Overjet, Inc.
    Date Cleared
    2021-05-19

    (114 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K192888
    Why did this record match?
    Device Name :

    Overjet Dental Assist

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Overjet Dental Assist 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 system is to be used by trained professionals including, but not limited to, dentists and dental hygienists.

    Device Description

    Overjet Dental Assist developed by Overjet Inc, 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.

    Overjet Dental Assist is a cloud native Software as a Medical Device that allows users to automate the measurement of interproximal bone levels for bitewing and periapical radiographs, review associated radiographs, view annotations, modify annotations.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    MetricAcceptance CriteriaReported Performance (Bitewing Radiographs)Reported Performance (Periapical Radiographs)
    Sensitivity>85%98.7%88.94%
    Specificity>85%95.0%95.96%
    Mean Absolute Difference (Bone Level Measurement)
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