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510(k) Data Aggregation

    K Number
    K042056
    Device Name
    AZ ULTRASONIC SYSTEM
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2004-09-30

    (62 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontic or endodontic use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "AZ Ultrasonic System." It primarily confirms that the device is substantially equivalent to a legally marketed predicate device. The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed study proving performance against specific acceptance criteria.

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