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510(k) Data Aggregation

    K Number
    K061804
    Device Name
    ZERION ALPHA, ; ZERION BETA
    Manufacturer
    ETKON INTERNATIONAL GMBH
    Date Cleared
    2006-10-06

    (101 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETKON INTERNATIONAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZERION is a dental ceramic designed for the fabrication of dental restorations by dental technicians. ZERION delivery state is a yttria (yttrium oxide) – stabilized tetragonal zirconia (zirconium oxide) powder, already partially sintered and made for machining by use of CAD/CAM-techniques. The machined frameworks (dental crown and bridge works) are then sintered to full density. ZERION is especially designed for use as framework (substructure) for dental restorations including single tooth or bridge type applications: on both anterior and posterior locations.
    Device Description
    ZERION is a dental ceramic being composed of partially sintered yttrum oxide stabilized zirconium oxide. ZERION is designed for manufacturing of all-ceramic dental restorations like crown, bridgework, and related dental appliances to be machined on milling centers using CAD/CAM techniques for design and processing. ZERION is designed for use as dental restorations like single tooth crowns or bridgeworks with up to two pontics for the anterior and posterior teeth regions equally. The restorations made-up of ZERION are destinated for the sole use of particular patients. ZERION is biocompatible and insoluble in water. Due to the outstanding high strength of densely sintered ceramic Zerion restorations enable dental technicians to design finely shaped, precise, and filigree framework. The characteristic white color offers an outstanding basis for aesthetical restorations. All these advantares together ensure safe, resistant, and effective dental restorations. ZERION substructures are well suited to be veneered with suitable dental porcelains using the layering technique. ZERION meets all applicable requirements for biocompatible dental restorations of the international standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 1335:1997 "Implants for surgery – Ceramic materials based on Yttria-stabilized tetragonal zirkonia". The partially sintered ZERION blanks are fabricated in two different types distincted by their presintered density and each type available as disks with different dimensions as follows: ZERION alpha, ZERION beta.
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