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510(k) Data Aggregation

    K Number
    K071267
    Date Cleared
    2007-05-18

    (11 days)

    Product Code
    Regulation Number
    872.3260
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN

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

    PerioSRP™ Tooth Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that PerioSRP™ Tooth Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain details about specific performance metrics, clinical study designs, or expert reviews as requested in your prompt.

    The document discusses:

    • The device name: PerioSRP™ Tooth Root Conditioner with NovaMin®
    • Its intended use: rapid relief of hypersensitivity associated with exposed tooth root dentin, and its effectiveness at occluding exposed dentinal tubules.
    • The FDA's determination of substantial equivalence and resulting market clearance.

    Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, ground truth, or study methodologies.

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