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510(k) Data Aggregation

    K Number
    K191443
    Device Name
    MSDI Dental Implants System
    Date Cleared
    2020-06-26

    (393 days)

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

    Medical Systems and Devices International Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MSDI Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support or prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    MSDI Dental Implants System implants are self-tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The MSDI's dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The MSDI's implant is a two piece device to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation. MSDI dental implants System is an internal hex implant system which provided in 3.3, 3.75, 4.2, 5.0 and 6.0 mm diameter for lengths of 8, 10, 11.5, 13 and 16mm. (There is no 6.0 mm diameter for the 16 mm length). The MSDI Dental Implants are to be used in combination with cover screws, healing caps and abutments according to commonly used protocol in the dental implantation field. The MSDI Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The implants are grit blasted and acid etched surface. The system includes standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi- unit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.
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