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510(k) Data Aggregation

    K Number
    K990670
    Device Name
    HELIOFORM GOLD-BASED ALLOY
    Manufacturer
    C. HAFNER GMBH & CO.
    Date Cleared
    1999-04-02

    (31 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    **C. HAFNER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for fixed and removable dental tooth replacement as follows: Crowns Inlays, Onlays, Overlays, Partial Crowns Telescopes, Cones, Overdentures Direct Technique Double Crown Systems Implant Suprastructures Bridge Structures Baseplates Detailed descriptions of the above indications can be found in the instructions for Use under 5.1 to 5.7
    Device Description
    The Helioform System is used to fabricate i. e. inlays, onlays and crowns by a electroforming process. Electroformed gold framework that can be fitted with ceramic facings are an ideal combination of function, esthetic appeal and biocompatibility. The galvano-forming procedure of the Helioform System is as follows: An electroconductive polyurethane duplicate die is used as a cathode in an electroplating tank. The electrolyte in this tank contains fine gold in solution (HF-Elektrolyt). When the electric current between the anode and cathode is activated, positively charged gold ions will travel from the electrolyte to the cathode, where they are deposited and form a gold plating. Galvanoformed parts are produced in Helioform technique using polyurethane dies. The dies are coated with a conductive silver spacer and serves as the cathode of the electroplating circuit. The electrolyte consists of a non-cyanide gold sulfite solution to which non-cyanide gold concentrate (HF-Goldkonzentrat) is continuously released to replace the gold precipitated on the cathode. When the electric current is turned on, gold will be deposited on the polyurethane die. The thickness of the laver depends on the duration of the live cycle (approximately 20 um per hour). It can be selected between 200 - 400 um. The galvanoformed item contains only fine gold with a fineness of 99,99 %. The amount of material required is only about 60 % of what a comparable casting alloy with high gold content would require.
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