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510(k) Data Aggregation

    K Number
    K982191
    Device Name
    CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1998-09-14

    (84 days)

    Product Code
    EBF,DAT
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.

    Device Description

    Chemical Cure Composite with Enamel Bond

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a dental composite material. It confirms that the device is substantially equivalent to previously marketed devices. However, it does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or effects of AI assistance. The document focuses on regulatory approval rather than detailed study results.

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