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510(k) Data Aggregation

    K Number
    K230237

    Validate with FDA (Live)

    Device Name
    Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
    Manufacturer
    Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
    Date Cleared
    2023-09-14

    (227 days)

    Product Code
    MQC,KMY
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dental Braces are indicated for the fabrication of orthodontic and dental appliances, such as Orthodontic Appliances, Orthodontic Retainers, Mouth Guards and Splints.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for dental braces, which are physical medical devices, not an AI/ML device. The document describes traditional regulatory clearance based on substantial equivalence to a predicate device, rather than performance criteria for an AI/ML diagnostic or assistive tool.

    Therefore, the requested information about acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, and training set size is not applicable to this document. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices.

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