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510(k) Data Aggregation

    K Number
    K070854
    Device Name
    GC MI PASTE PLUS
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2007-04-12

    (15 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GC MI PASTE PLUS

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

    To be used for cleaning and polishing procedures as part of professionally administered prophylaxis treatment. To relieve dental hypersensitivity and for the management of tooth sensitivity following in-office bleaching procedures, ultrasonic, hand scaling or root planning.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental product. It primarily focuses on regulatory approval and substantial equivalence to a predicate device.

    The document does not contain any information about clinical studies, acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.

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