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510(k) Data Aggregation

    K Number
    K042200
    Device Name
    MI PASTE
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2004-10-20

    (68 days)

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

    This product is to be used for cleaning and polishing as a professionally administered prophylaxis treatment. Secondarily, MI Paste can be used for the management of tooth sensitivity, postscaling, root planing and bleaching.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) clearance letter for a dental product called "MI Paste," classifying it and stating its indications for use. It doesn't include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a device performance study.

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