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510(k) Data Aggregation

    K Number
    K202918
    Device Name
    OsteoSync™ Ti Dental Mesh
    Manufacturer
    Sites Medical, LLC
    Date Cleared
    2021-07-14

    (288 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sites Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OsteoSync™ Ti Dental Mesh is intended for stabilization and support of bone grafts in dento-alveolar bony defect sites.
    Device Description
    The OsteoSync™ Ti Dental Mesh is a system of dental membranes intended for permanent fixation in adults and designed to aid in the reconstruction and augmentation of the alveolar ridges of the maxilla and mandible. They are available in a variety of sizes and shapes and can be contoured to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold sterile.
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