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510(k) Data Aggregation

    K Number
    K150056
    Device Name
    Luxisse+
    Date Cleared
    2015-05-06

    (114 days)

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

    HEANY INDUSTRIES INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Heany Industries, Inc. "Luxisse +" is non-implantable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges.
    Device Description
    Heany Industries Inc. "Luxisse +" is an all ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a block or disk shape. CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, single unit posterior and anterior crowns, and three unit anterior bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.
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    K Number
    K073314
    Device Name
    HEANY INDUSTRIES INC DENTAL XIRCONIA
    Date Cleared
    2008-02-21

    (87 days)

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

    HEANY INDUSTRIES INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Heany Industries Inc. Dental Zirconia is non implantable material intended for CAD/CAM fabrication of core material used in all-ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, crowns and bridges.
    Device Description
    Heany Industries Inc. Dental Zirconia is an all ceramic core material made of zirconium oxide. It is provided as a block or cisk shape. CAD/CAM fabrication of core matcrial can then be used to produce copings and or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.
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