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510(k) Data Aggregation

    K Number
    K042289
    Device Name
    MDI ORTHO
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2004-09-15

    (22 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K060126,K110392,K120861
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Implants are intended for single use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the (MDI ORTHO) Endosseous Implant. It confirms that the device is substantially equivalent to a legally marketed predicate device.

    However, this document does not contain the kind of detailed information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    This letter is a regulatory clearance document, not a scientific study report. It states that the device is substantially equivalent to a predicate, which means the FDA believes it is as safe and effective as a device already on the market. The specific studies and data supporting that determination are typically submitted in the full 510(k) submission, which is not provided here.

    Therefore, I cannot populate the requested information from the given text.

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