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510(k) Data Aggregation

    K Number
    K091878
    Device Name
    OSSEOLINK DENTAL IMPLANT SYSTEM
    Date Cleared
    2009-10-06

    (105 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL IMPLANT SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Implants: OsseoLink dental implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended. Prosthetic Abutments, Cover Screws & Healing Abutments: OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.
    Device Description
    The OsseoLink Dental Implant System is an endosseous type artificial tooth replacement system that is intended for use in prosthetic dentistry to support restorations that resemble a tooth or group of teeth.
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