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510(k) Data Aggregation

    K Number
    K051547
    Device Name
    POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30
    Manufacturer
    TPC ADVANCED TECHNOLOGY, INC.
    Date Cleared
    2005-07-14

    (31 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K983029
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PowerMAX Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits form teeth by application of an ultrasonic vibrating scaler tip to the teeth.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a dental ultrasonic scaler, not an AI/ML device, therefore the requested information regarding acceptance criteria, study data, sample sizes, and expert adjudication for AI/ML performance is not applicable. The document confirms that the device, PowerMAX Ultrasonic Scaler, is substantially equivalent to legally marketed predicate devices for dental cleanings and periodontal therapy.

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