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510(k) Data Aggregation

    K Number
    K982050
    Device Name
    MODEL MS-2 HANDPIECE
    Manufacturer
    PARKELL, INC.
    Date Cleared
    1998-09-02

    (83 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An air-powered handpiece intended for use in removing dental plaque and stains from teeth by projecting a stream of air, water and sodium bicarbonate onto tooth surfaces. Its use is contraindicated on patients with chronic respiratory disease, renal deficiencies or suffering chronic diarrhea and those on salt-free or salt-limited diet regimens.

    Device Description

    Parkell's MODEL MS-2 HANDPIECE is an air-powered handpiece intended for use in removing dental plaque and stains from teeth by projecting a stream of air, water and sodium bicarbonate onto tooth surfaces.

    AI/ML Overview

    This 510(k) summary describes a dental handpiece, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable.

    The submission is for the Parkell Model MS-2 Handpiece, an air-powered prophylaxis handpiece intended for removing dental plaque and stains. It is a traditional mechanical device, and its substantial equivalence determination is based on the comparison to a legally marketed predicate device (PROPHYFLEX 2, MODEL 2012), not on clinical performance studies typically associated with AI/ML devices.

    The document focuses on the device's intended use, contraindications, and regulatory classification, typical for a 510(k) premarket notification for a Class I mechanical device.

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