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510(k) Data Aggregation

    K Number
    K993488
    Device Name
    LIGHT-CORE
    Manufacturer
    BISCO, INC.
    Date Cleared
    1999-11-10

    (26 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K882006
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Core build-up composite for use with a 4th or 5th generation adhesive system.

    Device Description

    Light-Core is a translucent, fiber-reinforced, light-cured core build-up composite for use with a 4th or 5th generation adhesive system.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for a dental core build-up composite called "Light-Core™", outlining its characteristics and comparing it to a predicate device. It includes the intended use, chemical composition, physical/mechanical properties, biocompatibility, depth of cure, physical description, and handling time. However, it does not specify any quantitative acceptance criteria or a study's results against such criteria.

    Therefore, I cannot provide the requested information.

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