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510(k) Data Aggregation

    K Number
    K040661
    Manufacturer
    Date Cleared
    2004-06-09

    (89 days)

    Product Code
    Regulation Number
    872.6030
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    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

    Not Found

    AI/ML Overview

    This is a tough one! I cannot find the acceptance criteria or study details within the provided text. The document is primarily an FDA clearance letter for a dental prophy paste, confirming its substantial equivalence to other legally marketed devices. It doesn't contain any information about performance studies, acceptance criteria, or specific metrics.

    Therefore, I cannot generate the table or answer the questions you've posed. To provide that information, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) submitted to the FDA, a clinical study report, or even the 510(k) submission itself which would contain the study details.

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