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510(k) Data Aggregation

    K Number
    K202855
    Device Name
    Orthodontic Facemask
    Manufacturer
    ITA.O Italian Orthodontic System S.r.l.
    Date Cleared
    2021-06-21

    (266 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Orthodontic Facemask

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

    Orthodontic Facemask is used as a treatment option for Class III malocclusions.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for an Orthodontic Facemask, which is a physical device, not an AI/ML powered software device. Therefore, the questions related to AI/ML powered software performance, such as acceptance criteria, study details, expert consensus, ground truth, and training/test set specifics, are not applicable. The provided document focuses on regulatory approval for the physical device.

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