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510(k) Data Aggregation

    K Number
    K991492
    Device Name
    LC COMPOSITE
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    1999-12-02

    (218 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LC Composite is indicated for use in anterior and posterior restorations with its esthetics and strength

    Device Description

    LC Composite

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Harry J. Bosworth Company for their device "LC Composite". It does not contain information about acceptance criteria, study details, or performance metrics. Therefore, it is impossible to extract the requested information from this document.

    The letter confirms that the device is substantially equivalent to a predicate device and allows it to be marketed. The "Indications for Use" statement simply says: "LC Composite is indicated for use in anterior and posterior restorations with its esthetics and strength."

    To answer your questions, one would need access to the actual 510(k) submission document (K991492), which would contain the performance data and details of any studies conducted.

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