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510(k) Data Aggregation

    K Number
    K242366
    Device Name
    OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
    Manufacturer
    Overfibers S.r.l.
    Date Cleared
    2025-01-10

    (154 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Overfibers S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or zirconia, composite or metal; 2-3 unit Maryland bridges and 3-unit inlay/onlay bridges (to be avoided for patients with bruxism or periodontitis). 2. Definitive cementation of endocanal posts. 3. Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and natural teeth. 4. Definitive cementation of zirconium oxide superstructures for two-unit abutments
    Device Description
    OverCEM is dual-curing, self-adhesive resin luting cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. The operating principle of the device is based on two reactions, one self-curing. OverCEM is designed to strongly and stably connect reconstruction materials and endocanal posts to patients' teeth or implants.
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