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510(k) Data Aggregation

    K Number
    K083886
    Device Name
    SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004
    Manufacturer
    Date Cleared
    2009-03-23

    (84 days)

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

    SIMPLER ONE STOP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Simpler Mini Implants (ID SM3002-4) and the Simpler HA Mini Implants (ID SM5002-4) are intended to provide long term intra-bony applications. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. They may also be used for temporary support for partial and fully edentulous restoration in the mandible and maxilla. They may be used for full or partial edentulism and are used as an option to provide a minimally invasive surgical intervention.
    Device Description
    The HA coated Simpler Mini Implants (K 083886) are identical to the Simpler Mini Implants (K073645) except for the addition of the HA coating to the threaded area of the implants. Natural dentition is composed of a subgingival root and a supragingival crown. For both coated and uncoated mini implant designs tend to minic this structure and transitional implants are no exception. The implant base and the abutment are all in one piece. They are 2.5mm in diameter with a choice of 10, 13 or 15 mm in length for both the Simpler HA mini implants. For partial and complete edentulism, a retaining a rubber ring acts like a socket to receive the ball on the top of the implant. A soft liner is placed into the patient's denture to adapt around the ball portion of the implant to provide retention to the denture. When seated, the denture rests on the gum tissue.
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