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510(k) Data Aggregation

    K Number
    K111120
    Device Name
    CSM SUBMERGED-R IMPLANT SYSTEM
    Manufacturer
    CSMIMPLANT
    Date Cleared
    2011-10-14

    (176 days)

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

    CSMIMPLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSM submerged-R Implant System is especially designed for use in dental implant surgery. According to the widely accepted clinical studies successful osseointegration between fixture and the live bone depends on surgical implantation under proper conditions, shape of fixture and surface treatment technique. Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. In case of Customized Hand Milling Abutment, its wall thickness is 2mm and height is 12mm. It can be reduced into Max. 7mm. The margin of the product can be modified up to Max 20°. In case of Non-Hex Cementation Abutment, it is a bridge type. Two or more products must be used. Under part of abutment is made in order to avoid restriction in connecting work.
    Device Description
    The CSM submerged - R implant system includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper jaw and serve as a tooth root replacement providing a stable foundation for restorations. This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.
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