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510(k) Data Aggregation

    K Number
    K024343
    Device Name
    BUTLER GUM PROPHY PASTE WITH NOVAMIN
    Manufacturer
    USBIOMATERIALS CORP.
    Date Cleared
    2003-07-11

    (196 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K002989
    Why did this record match?
    Applicant Name (Manufacturer) :

    USBIOMATERIALS CORP.

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

    Butler GUM Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Secondarily, Butler GUM® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.

    Device Description

    Bulter GUM® Prophylaxsis Paste with NovaMin® is intended for use in a professionally administered cleaning and polishing procedure during the prophylaxis treatment. The NovaMin® in the paste reduces sensitivity by occluding dentinal tubules.

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a prophylaxis paste, primarily discussing its substantial equivalence to a predicate device and its intended use. It does not contain the details you've requested about device performance, study designs, expert involvement, or ground truth establishment.

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