LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051798
    Device Name
    OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
    Manufacturer
    OSTEOMED L.P.
    Date Cleared
    2006-04-07

    (276 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K040891,K041651
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only.

    Device Description

    This submission describes the OsteoMed Orthodontic Anchor Plating System which includes plates intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. The OsteoMed Orthodontic Anchor Plates are intended for single use only. The OsteoMed Orthodontic Anchor Plating System plates are provided in various shapes and sizes and are fixed to bone via Auto-Drive screws.

    AI/ML Overview

    The provided text describes a 510(k) submission for the OsteoMed Orthodontic Anchor Plating System. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

    Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance, sample sizes, ground truth establishment, or expert involvement in the evaluation of device performance against predefined criteria.

    The 510(k) summary explicitly states:
    "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Ortho Anchorage System (K040891) and the Stryker Leibinger Skeletal Anchoring System (K041651). Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed Orthodontic Anchor Plating System does not raise any new safety or effectiveness issues."

    This indicates that the submission's focus was on demonstrating that the new device is substantially equivalent to already legally marketed devices, and therefore, does not necessitate a new study to prove its performance against specific acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1