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510(k) Data Aggregation

    K Number
    K983876
    Device Name
    MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC
    Manufacturer
    MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND
    Date Cleared
    1998-12-16

    (44 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND

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

    The denture materials manufactured by Keystone Industries are intended to be used to form new dentures or to repair fractured dentures. They are to be used only by professional dental practitioners who make or repair dentures for patients.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a dental device (denture acrylic material) and does not contain information about acceptance criteria, device performance studies, or ground truth establishment. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail the technical studies typically performed for AI/ML-based medical devices as per your request.

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