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510(k) Data Aggregation

    K Number
    K241151
    Device Name
    LUXEN 5G
    Manufacturer
    Dentalmax Co., Ltd
    Date Cleared
    2024-09-30

    (158 days)

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

    Dentalmax Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LUXEN 5G is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.
    Device Description
    LUXEN 5G is ceramic block used to create customized dental restorations using CAD/CAM system. LUXEN 5G block are available in three shapes (Block, Wieland, D95) and various thickness sizes. LUXEN 5G is composed of yttria-stabilized zirconia and 3~4 mol % TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia.
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    K Number
    K212548
    Device Name
    LUXEN CL Dental Liquid
    Manufacturer
    DENTALMAX Co., Ltd.
    Date Cleared
    2021-12-06

    (115 days)

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

    DENTALMAX Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.
    Device Description
    The subject device is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 100 shades are available in 10ml, 30ml, 50ml, 50ml and 100ml volumes. Luxen CL-Diluent and Luxen CL-Pontic Liquid are used to dilute the color of other products. Luxen CL-Pontic and Luxen-CL Diluent is used to dilute Base liquid and special color liquid.
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    K Number
    K171585
    Device Name
    LUXEN Zr, LUXEN Smile
    Manufacturer
    Dentalmax Co., Ltd
    Date Cleared
    2018-10-31

    (518 days)

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

    Dentalmax Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks. LUXEN Smile is indicated for the production of full ceramic crowns, onlays, 3bridges and inlay bridges (anterior and molar).
    Device Description
    LUXEN Zr and LUXEN Smile are used for custom made dental restorations using a CAD/CAM system. The LUXEN Zr and LUXEN Smile are provided in 4 different shapes - block, disk, Wieland and D-95. The LUXEN Zr is composed of 3 mol% TZP. LUXEN Smile is composed of 5 mol% TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia, and ISO 6872:2015 Type2, class 4b for 5Y-TZP Zirconia, respectively.
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