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510(k) Data Aggregation

    K Number
    K061252
    Device Name
    PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
    Manufacturer
    PRIMUS CONSULTING
    Date Cleared
    2007-02-12

    (284 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K020394
    Why did this record match?
    Reference Devices :

    K020394

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

    The Pre-Cemented Orthodontic Bracket System is indicated for use in bonding orthodontic appliances for orthodontic treatment.

    Device Description

    The Pre-Cemented Orthodontic Bracket System consists of precemented orthodontic brackets and an optional bonding tray. The orthodontic brackets and component used in the application are currently marketed medical devices.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a "Pre-Cemented Orthodontic Bracket System." However, it is not a study that proves the device meets acceptance criteria.

    The document is a notification from the FDA confirming that the agency has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that based on the provided information, the FDA believes the new device has the same intended use and technological characteristics as a device already on the market, and therefore does not require a premarket approval application (PMA).

    The document does NOT contain:

    • Acceptance criteria for performance.
    • Results from any studies (clinical or bench) comparing the device's performance against specific metrics.
    • Information about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

    The 510(k) summary explicitly states: "All of the components found in the Pre-Cemented Orthodontic Bracket System are legally marketed devices or are found in legally marketed devices. As there are no changes in formulation from the predicate devices, we believe that additional biocompatibility testing is not required." This suggests that the substantial equivalence argument relies on the existing safety and effectiveness of the predicate devices and their components, rather than new, independent performance testing of the combined system against defined acceptance criteria.

    Therefore, I cannot populate the requested table and information as the provided text does not contain the necessary details about acceptance criteria or a study proving the device meets them.

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