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510(k) Data Aggregation

    K Number
    K051424
    Device Name
    HYDROGUM 5
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2005-07-15

    (44 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYDROGUM 5

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

    Zhermack HYDROGUM 5 is a dental impression material intended to be placed on a preformed tray and used to reproduce the structure of a patients teeth, inlays and dentures. It is also intended to provide models of outletted in as dental inlays and dentures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA and does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria.

    The document states that the FDA has reviewed the 510(k) submission for the "Hydrogum 5" dental impression material and determined it is substantially equivalent to legally marketed predicate devices. This means the device is considered as safe and effective as other similar devices already on the market, but it does not provide details of specific performance criteria or a study proving it meets them.

    Therefore, I cannot provide the requested information based on the provided text.

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