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    K Number
    K222723
    Device Name
    AMBARINO High-Class
    Manufacturer
    Creamed GmbH & Co. Produktions- und Handels KG
    Date Cleared
    2022-09-09

    (1 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Creamed GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMBARINO® High-Class is indicated for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.
    Device Description
    The AMBARINO® High-Class CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion than a pure resin (similar to natural enamel). This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use.
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