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510(k) Data Aggregation

    K Number
    K051776
    Device Name
    PROTEGE ULTRASONIC INSERT
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2005-07-13

    (12 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROTEGE ULTRASONIC INSERT

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

    Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.

    Device Description

    Protégé Ultrasonic Insert Devices

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for dental ultrasonic inserts. This type of document declares substantial equivalence to a predicate device and does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, or ground truth that would typically be found in a clinical study report or a more comprehensive technical document.

    Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory approval and does not provide specifics on device performance beyond stating its intended use.

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