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510(k) Data Aggregation

    K Number
    K252469

    Validate with FDA (Live)

    Date Cleared
    2025-11-06

    (92 days)

    Product Code
    Regulation Number
    872.3200
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MAGNABOND SE

    • Bonding agent for direct restorations of all classes of cavities using light-curing composite or compomer filling materials
    • Bonding agent for core build-ups that are made with light-curing composites

    MAGNABOND UNIVERSAL

    • Bonding agent for direct restorations of all classes of cavities using light-curing composite or compomer filling materials
    • Bonding agent for core build-ups that are made of light-curing composites
    • Bonding agent for intraoral repair of composite or compomers restorations, porcelain fused to metal (PFM), ceramic veneers and all-ceramic restorations without an additional primer
    • Sealing of cavities prior to amalgam restorations
    • Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
    • Treatment of hypersensitive teeth
    • Protective varnish for glass ionomer cement restorations

    COMBINED WITH MAGNABOND UNIVERSAL DCA:

    • Bonding agent for direct restorations of all classes of cavities using self or dual curing composites and core build-ups
    • Bonding agent for indirect restorations using self or dual curing luting composites/cements
    • Luting of root posts using self or dual curing luting composites/cements
    Device Description

    Not Found

    AI/ML Overview

    N/A

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