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510(k) Data Aggregation

    K Number
    K252151

    Validate with FDA (Live)

    Device Name
    els unibond
    Manufacturer
    Saremco Dental AG
    Date Cleared
    2025-12-05

    (149 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K210804,K241445,K110302
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Direct restorations with light-curing composite-based materials.
    • Indirect restorations: at the use of light-curing composite cements to fix inlays, onlays, crowns and bridges
    Device Description

    els unibond is an extra low shrinkage, light-curing, single component, self-etching adhesive, used to create a permanent marginal-gap-free adhesion between the tooth structure and the light-curing filling/fixing material, e.g. els extra low shrinkage® composite and els extra low shrinkage® flow.

    AI/ML Overview

    N/A

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