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510(k) Data Aggregation

    K Number
    K043131
    Device Name
    TORPICALGIN
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2004-12-15

    (33 days)

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

    TORPICALGIN

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

    Zhermack TROPICALGIN is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.

    Device Description

    Zhermack TROPICALGIN is a dental impression material.

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter for a dental impression material named "Tropicalgin". It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the provided text. The document is regulatory correspondence and does not describe a performance study or its results.

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