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510(k) Data Aggregation

    K Number
    K984467
    Device Name
    FUSICRYL
    Manufacturer
    MICRO DENTAL LABORATORIES
    Date Cleared
    1999-02-24

    (70 days)

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

    FUSICRYL

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

    Fabrication of dental prostheses like full dentures and metal free partials.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a dental material named "FUSICRYL". It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance of the device based on substantial equivalence, not on the detailed technical performance data that would typically be found in a study report.

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