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510(k) Data Aggregation

    K Number
    K140202
    Device Name
    TRAUSIM DENTAL IMPLANT SYSTEM
    Date Cleared
    2014-12-12

    (319 days)

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

    JIANGSU TRAUSIM MEDICAL INSTRUMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Trausim Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient The Trausim Dental Implants System's prosthetic components include abutment, healing cap and screw. The abutment is as dental implant systems essentially a connection part of dental implant and denture. The healing cap is used for covering the dental implant during healing period; the aim at avoiding soft tissue (gingival) get into the hole of dental implant, and shaping the gingival aesthetic form.
    Device Description
    The Trausim Dental Implants System's prosthetic components include abutment, healing cap and screw. The abutment is as dental implant systems essentially a connection part of dental implant and denture. The healing cap is used for covering the dental implant during healing period; the aim at avoiding soft tissue (gingival) get into the hole of dental implant, and shaping the gingival aesthetic form.
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