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510(k) Data Aggregation

    K Number
    K991491
    Device Name
    FLC COMPOSITE
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    1999-06-21

    (54 days)

    Product Code
    EBF
    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

    FLOWABLE LIGHT CURE COMPOSITE: This fluid composite will flow into difficult areas and therefore indicates its use for Class V and Class III restorations.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents (FDA 510(k) clearance letter and Indications for Use) do not contain information regarding
    acceptance criteria for device performance, a study to prove acceptance criteria, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

    The documents primarily focus on the regulatory clearance for the "FLC Composite" device based on its substantial equivalence to a legally marketed predicate device. The Indications for Use section only specifies the intended clinical applications for the device (Class V and Class III restorations due to its flowable nature).

    Therefore, I cannot provide the requested information based on the input.

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