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510(k) Data Aggregation

    K Number
    K101814
    Device Name
    DIRECT CROWN NATURAL 1
    Manufacturer
    CANDULOR USA, INC.
    Date Cleared
    2010-09-27

    (90 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIRECT CROWN NATURAL 1

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

    Direct Crown Natural 1 is intended for the fabrication of short and long term temporary crowns and bridges (up to 12 months) using the Direct Crown shell teeth.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental device called "Direct Crown Natural 1," which is a temporary crown and bridge resin.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not describe:

    • Acceptance criteria and reported device performance (in a table or otherwise).
    • Details of any study (sample size, data provenance, expert qualifications, ground truth establishment, MRMC studies, standalone performance, training set size).

    The document is purely an FDA clearance notification, not a study report or clinical trial summary.

    Therefore, I cannot provide the requested table or answer the specific questions about device performance studies based on the provided text.

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