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510(k) Data Aggregation

    K Number
    K251775
    Device Name
    RODIN Cement
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2025-09-02

    (84 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Rodin Envision veneer cement (Light Cure):

    • Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
    • Only use Rodin Envision veneer cement Light Cure for restorations with a low thickness of <2mm that have sufficient translucency.

    Rodin Luting Cement (Dual Cure):

    • Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays, partial crowns, crowns, bridges).
    • Restorations made of opaque ceramics, e.g. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.
    Device Description

    Not Found

    AI/ML Overview

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