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510(k) Data Aggregation

    K Number
    K051207
    Device Name
    CAVEX ORTHOTRACE
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2005-06-21

    (41 days)

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

    CAVEX ORTHOTRACE

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

    Cavex Orthotrace alginate impression material is a dental impression material based on alginate. It is about taking impressions of the oral cavity with the purpose of constituting a gypsum cast that is a copy of the situation in the mouth. Cavex Orthotrace has an extra fast setting, high elasticity, high tear resistance, can be poured twice with gypsum and is proven Orthotrace is particularly suited for orthodontics

    Device Description

    Cavex Orthotrace Alginate impression material

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental impression material named "Cavex Orthotrace," dated June 21, 2005. It confirms the device's substantial equivalence to legally marketed predicate devices.

    The letter details the regulatory classification, general controls provisions of the Act, and contact information for further inquiries. However, it does not include any technical specifications, performance data, clinical study results, or information about acceptance criteria or how they were met. It merely states that the device is substantially equivalent for the indications for use.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about study characteristics like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is absent in the provided text.

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