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510(k) Data Aggregation

    K Number
    K013336
    Device Name
    XANTALGIN CRONO
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2001-10-29

    (20 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

    Xantalgin Crono is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

    Device Description

    Xantalgin Crono is a dental impression material based on alginate. Xantalgin Crono has the special characteristic of being a color-changing alginate: it becomes blue upon contact with water in the mixing bowl. It changes to violet indicating the end of the mixing time and loading the tray. Then it changes to pink indicating the moment to insert the tray into the mouth of the patient and finally it changes to white indicating the end of the setting time in the mouth.

    AI/ML Overview

    I'm sorry, but without further context or additional documents describing specific acceptance criteria and study details for the device "Xantaglin Crono Alginate Impression Material," I am unable to provide the comprehensive answer you've requested.

    The provided FDA letter (K013336) is a 510(k) clearance letter, which indicates the device has been found substantially equivalent to a predicate device. It defines the device, its intended use, and confirms it can be marketed. However, this letter does not contain information about the acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment relevant to your detailed questions.

    To answer your request, I would need a different type of document, such as:

    • A premarket submission (510(k) summary or full submission) for the device.
    • A clinical study report for the device.
    • Instructions for Use (IFU) or labeling that details performance claims and supporting data.
    • A peer-reviewed publication or technical report about the device's performance.

    If you can provide such documents, I would be happy to extract the requested information.

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