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510(k) Data Aggregation

    K Number
    K121281
    Device Name
    SIMPLI SIMPLER IMPLANT SYSTEM
    Date Cleared
    2013-04-05

    (340 days)

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

    SIMPLER IMPLANT SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SIMPLI Simpler Implant System is indicated for use in surgical and restorative applications for placement of implants in the mandible and maxilla to provide support for prosthetic devices such as artificial teeth to provide chewing function to a patient with missing teeth. It is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The SIMPLI™ Simpler implant system is a threaded, endosseous dental implant designed to be one piece immediate load as well as delayed load to replace one, several or all missing teeth.
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