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510(k) Data Aggregation

    K Number
    K983966
    Device Name
    NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    1999-01-29

    (84 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K912945
    Predicate For
    K061427
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

    Device Description

    NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures. The new device contains fluoride, triclosan®, an abrasive, a sweetener, water, flavoring, color, thickeners, and preservatives.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental prophylaxis paste. It details the device's description, intended use, and technological characteristics, and references predicate devices. However, the document does not contain the specific information requested about acceptance criteria, device performance from a study, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

    Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document primarily focuses on establishing substantial equivalence to a predicate device, relying on the safety of its components and prior use in other dental products.

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