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510(k) Data Aggregation

    K Number
    K050417
    Device Name
    ELITE IMPLANT
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2005-07-19

    (151 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ELITE IMPLANT is a radiopaque dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a dental patient's teeth. Additionally, it is intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and onlays. Its radiopacity is intended to assist in detecting possible fragments of residual material.

    Device Description

    ELITE IMPLANT is a radiopaque dental impression material.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental impression material named "Elite Implant." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information.

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