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510(k) Data Aggregation

    K Number
    K980049
    Device Name
    BONETRAP
    Manufacturer
    BLADHS PLAST AB
    Date Cleared
    1998-08-11

    (217 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The boneTRAP is designed for use in various oral surgical procedures (implant surgery, periodontal surgery, etc.) where the oral surgeon desires to collect a patient's own bone particles and other tissue fragments for later use in bone or tissue transplantation.

    Device Description

    boneTRAP is a sterile, disposable plastic trap for collecting bone particles.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "BoneTRAP" device. This type of document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

    Therefore, I cannot extract the requested information from the given text. The letter only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include technical specifications, study methodologies, or performance metrics.

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