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510(k) Data Aggregation

    K Number
    K022066
    Device Name
    REGISTRADO X-TRA
    Manufacturer
    VOCO GMBH
    Date Cleared
    2002-08-14

    (50 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

    Registrado X-tra is intended for reproducing the structure of a patient's teeth and gums, to provide models in bite registration, fixing of facebow registration, and as a locator material for an intraoral pin tracing template.

    Device Description

    Not Found

    AI/ML Overview

    The document is a 510(k) clearance letter from the FDA for a dental impression material named "Registrado X-tra". It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    The letter is primarily a regulatory approval document confirming substantial equivalence and outlining ongoing compliance requirements for the manufacturer. It does not include the technical study details typically found in a device's submission dossier.

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

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