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510(k) Data Aggregation

    K Number
    K073622
    Device Name
    EASY GRIP DENTAL IMPLANT SYSTEM
    Date Cleared
    2008-05-14

    (140 days)

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

    T.F.I. SYSTEM S.R.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EASY GRIP implants are designed for use in partially edentulous mandibles or maxillae for attachment of complete denture prostheses or as a terminal or intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement. EASY GRIP implant system uses a two-stage implantation procedure or one-stage procedure.
    Device Description
    EASY GRIP dental implants are root-form endosseous dental implant devices made out of biocompatible medical titanium, commercially pure or alloyed. There are three types of implants: cylindrical, anatomical, conical, available in different diameters from 3.3 to 5.5 mm and lenghts that vary from 8 to 16 mm. The anchorage surface of the implant is roughened by a sand-blasting and an acid-etching process, for better osseointegration. This submission also include compatible screws and prosthetic components.
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