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510(k) Data Aggregation

    K Number
    K083297
    Device Name
    PITT-EASY DENTAL IMPLANT SYSTEM
    Manufacturer
    SYBRON IMPLANT SOLUTIONS GMBH
    Date Cleared
    2009-01-28

    (79 days)

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

    SYBRON IMPLANT SOLUTIONS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
    Device Description
    The Pitt-Easy Dental Implant System is an endosseous dental implant that is intended to be surgically placed in bone of the upper or lower jaw arches to provide support for dental prosthesis. The Pitt-Easy Implant consists of two component parts: the implant (root component) and a threaded healing cap. In addition, attachments that are screw-retained, such as restorative abutments, are available for attachment to the root component.
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