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510(k) Data Aggregation

    K Number
    K060376
    Device Name
    SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
    Date Cleared
    2006-04-25

    (70 days)

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

    SIMPLER IMPLANT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Simpler HA Coated Threaded Dental Implants are endosseous threaded implants used as an artificial root structure to replace missing teeth. They are used to support crowns. bridges, or dentures in the maxilla or mandible area of the mouth.
    Device Description
    Simpler Threaded HA Coated, Models ST 5002-5016, Simpler T
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