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510(k) Data Aggregation

    K Number
    K043472
    Device Name
    MEDIN TECH ZIRCONIA-CP10, SS1000
    Manufacturer
    MEDIN TECH
    Date Cleared
    2005-01-18

    (33 days)

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

    MEDIN TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for surgical implant and more recently for many uses in the dental industry. Intended for preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently will be used with porcelain overlay for translucence and related effects. Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
    Device Description
    Medin Tech Zirconia™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern CAD/CAM methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and refurned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Medin Tech Zirconia" prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, except that their application more closely resembles gold inlavs 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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