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510(k) Data Aggregation

    K Number
    K983374
    Device Name
    AGATHA-A-H2010
    Manufacturer
    MIDIAN INTL.
    Date Cleared
    1998-12-23

    (89 days)

    Product Code
    EFS
    Regulation Number
    872.6510
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDIAN INTL.

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

    To Remove adherent plaque and debris from the teeth and oral mucosa, to Reduce tooth decay in patients who are Physically unable to perform brushing. To Prevent Aspiration, which may be associated with mechanical brushing only in these patients.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Agatha-A-H2010." It indicates that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

    Therefore, I cannot provide the requested information based on the provided text. The letter only confirms that the device can be marketed and specifies its intended use and regulatory class.

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