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510(k) Data Aggregation

    K Number
    K042548
    Device Name
    CERASYS - ZR
    Manufacturer
    CERASYS, INC.
    Date Cleared
    2004-12-03

    (74 days)

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

    CERASYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to restore carious lesions or structural defects in teeth. Intended to restore carious and and II. V. V. V. V. V. V. V. V. Intended to restore carrous rollows for the V (Inlays & Onlays) It is intended for use in cavities Classes I, II, V (Inlays & Onlays) It is intended for use in cavities Classes it, in (223) and as a restorative material intended for veneers, crowns, and bridges.
    Device Description
    CeraSys - ZR is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentists prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or only prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesive materials. CeraSys - ZR ceramic is an alternative to gold, amalgam, porcelain, or composite filling materials, except that their application more closely resembles gold inlys or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.
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