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510(k) Data Aggregation

    K Number
    K252785

    Validate with FDA (Live)

    Device Name
    TopCEM Vigor SA Self-Adhesive Resin Cement
    Manufacturer
    Rizhao Huge Biomaterials Company, Ltd.
    Date Cleared
    2025-12-12

    (101 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K100756
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Cementation of all-ceramic, composite, and metal crowns, bridges, inlays, onlays, dental posts; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (contraindicated for patients with bruxism or periodontitis).
    • Cementation of fiber posts.
    • Cementation of all-ceramic, composite, and metal restorations on implant abutments.
    Device Description

    TopCEM Vigor SA Self-Adhesive Resin Cement is a dual-curing (chemical and/or light cure) luting cement containing paste-paste of Base and Catalyst. The cement contains inorganic fillers, and the inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. The mixing ratio, based on volume, is 1 part base paste: 1 part catalyst paste. TopCEM Vigor SA Self-Adhesive Resin Cement is delivered in double-barrel syringes. TopCEM Vigor SA Self-Adhesive Resin Cement is radiopaque, allowing for easy identification on radiographs. It belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The curing mechanism of the predicate devices and subject device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.

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