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510(k) Data Aggregation

    K Number
    K103528
    Device Name
    IPS EMPRESS DIRECT FLOW
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-02-25

    (87 days)

    Product Code
    EBF,EBC,EBD
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K122521
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations
    Repair of composite restorations (in particular filling of voids, levelling out of porosities and minor chips)
    As a thin (< 0.5mm) initial layer under Class I and II restorations
    Small restorations of all types
    Extended fissure sealing
    Splinting of mobile teeth
    Blocking out of undercuts
    Repair of composite and ceramic veneers

    Device Description

    Not Found

    AI/ML Overview

    This document describes the FDA's 510(k) clearance for the IPS Empress Direct Flow device. It does not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, sample sizes, or expert qualifications as it pertains to a study in the context of AI/ML device approval.

    Therefore, I cannot provide the requested information. The document is a regulatory clearance letter, not a study report.

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