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510(k) Data Aggregation

    K Number
    K993238
    Device Name
    FORTOSS-CEMA
    Manufacturer
    BIOCOMPOSITES LTD.
    Date Cleared
    2000-01-14

    (109 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fortoss-Cema™ is used as a barrier over bone graft materials to prevent particle migration in an osseous defect.
    Fortoss-Cema™ is indicated for use as a barrier in placement over bone graft material to r orcess only - barrier and prevent particle migration in an osseous defect.

    Device Description

    Fortoss-Cema™ is a medical grade calcium sulfate powder and mixing diluent The blended materials form a creamy paste which set to form a barrier over bone graft materials.
    Fortoss-Cema™ is a resorbable pre-measured powder which, when blended with the supplied sterile diluent, forms a setting paste.

    AI/ML Overview

    I am sorry, but the provided text only contains a 510(k) summary for the Fortoss-Cema™ device, which describes its intended use, design, and substantial equivalence to a predicate device. It does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request for this information.

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