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510(k) Data Aggregation

    K Number
    K051705
    Device Name
    IPS E.MAX CAD/IPS E.MAX ZIRCAD
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2005-10-14

    (112 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 CAD/IPS E.MAX ZIRCAD

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

    IPS e.max CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, and full ceramic 3-unit anterior bridges.

    IPS e.max ZirCAD consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays and 3- and 4-unit bridges and inlay bridges (anterior and molar.)

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding dental CAD/CAM materials (IPS E.MAX CAD/IPS E.MAX ZIRCAD). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested table and information based on the given document. The document is primarily an administrative letter confirming substantial equivalence to a predicate device, not a detailed study report.

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