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510(k) Data Aggregation

    K Number
    K251084
    Device Name
    zirkon; structure; LFU shades, stains and glazes
    Manufacturer
    estetic ceram ag
    Date Cleared
    2025-06-05

    (57 days)

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

    estetic ceram ag

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Types of restorations: 1. Anterior and posterior crowns 2. Veneers, inlays, onlays.
    Device Description
    zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.
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