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510(k) Data Aggregation

    K Number
    K040547
    Device Name
    AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2004-03-19

    (17 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE

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

    The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, two component, dual-cure (light-activated with a post-cure chemical-cure) resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic brackets to teeth. This latter type of cure is used when sufficient light exposure is not possible due to the opacity of the bracket.

    The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled, two component, dual-cure resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic bands.

    The adhesive can also be used to cement dental restorations (crowns, bridges, veneers, inlays, onlys, etc.) where a filled, two component, dual-cure resin is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond or cement a dental restoration.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental adhesive device, Aegis® ORTHO Dual-Cured Orthodontic Adhesive. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

    The document primarily addresses the substantial equivalence of the device to existing predicate devices under the FDA's 510(k) pathway. This pathway is for medical devices that are substantially equivalent to a legally marketed predicate device and does not typically involve the detailed performance studies, acceptance criteria, or ground truth establishment that would be associated with AI/ML devices.

    Therefore, for your request, I cannot provide the information as it relates to an AI/ML device study because:

    • No acceptance criteria are mentioned for an AI/ML device. The document discusses regulatory compliance for a physical dental adhesive.
    • No study proving device performance in the context of AI/ML is detailed. The letter acknowledges the device's substantial equivalence to predicate devices, but this is a regulatory determination, not a performance study for an AI/ML algorithm.
    • None of the requested specific categories (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) are present in the document. These are relevant to AI/ML device evaluation, not a physical dental adhesive.
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