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    K Number
    K043054
    Device Name
    GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    2005-02-18

    (105 days)

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

    GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL

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

    Sultan Genie Magic Mix™ Ultra Hydrophilic Impression Material is intended for use as a dental impression material, compatible with all techniques including dual-phase, monophase and dual impression techniques. The material is dispensed from an automatic mixing machine system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or study details for a device. The document is a 510(k) clearance letter from the FDA for a dental impression material, outlining its substantial equivalence to a predicate device and its intended use. It does not include performance metrics or study designs.

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