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510(k) Data Aggregation

    K Number
    K120134
    Device Name
    IPS E.MAX PRESS MULTI
    Manufacturer
    IVOCLAR VIVADENT AG
    Date Cleared
    2012-06-25

    (160 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IPS E.MAX PRESS MULTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IPS e.max Press and IPS e.max Press Multi is an all-ceramic system for the creation of
    Occlusal veneers
    Thin Veneers
    Veneers
    Inlays
    Onlays
    Crowns in the anterior and posterior region
    3-unit bridges in the anterior region
    3-unit bridges in the premolar region up to the second premolar as the terminal abutment
    Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental device (IPS e.max Press and IPS e.max Press Multi). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.

    Therefore, I cannot provide the requested information.

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