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510(k) Data Aggregation

    K Number
    K030644

    Validate with FDA (Live)

    Device Name
    CONTEC DUO, CONTEC LC, CONTEC LCR
    Manufacturer
    DENTAURUM
    Date Cleared
    2003-11-21

    (266 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ConTec: Duo, ConTec LC, ConTec LCR are adhesive compounds that are used to fix orthodontic appliance to teeth.

    Device Description

    ConTec Duo, ConTec LC, Contec LCR are adhesive compounds

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for dental adhesive devices (ConTec Duo, ConTec LC, ConTec LCR). It confirms that the devices are substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, study data, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

    Therefore, I cannot answer the request with the information provided. The typical 510(k) clearance letter focuses on regulatory approval based on substantial equivalence, not detailed study results as would be found in a clinical trial report or a scientific publication.

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