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510(k) Data Aggregation

    K Number
    K051859
    Device Name
    SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM
    Manufacturer
    SIN SISTEMA DE IMPLANTE NACIONAL LTDA
    Date Cleared
    2005-09-23

    (77 days)

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

    SIN SISTEMA DE IMPLANTE NACIONAL LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sistema de Implante Nacional Dental Implant System is intended to be surqically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Restorations supported by two or more Sistema de Implante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved.
    Device Description
    Sistema de Implante Nacional Dental Implants are threaded, tapered and straight endosseous dental implants made of commercially pure titanium and intended for use with Sistema de Implante Nacional System abutments and instruments. The implants are offered in a multiple of lengths and diameters. They are offered with a machined surface or acid etched.
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