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510(k) Data Aggregation

    K Number
    K053329
    Device Name
    KORLEX-GR GINGIVAL RETRACTION PASTE
    Manufacturer
    BIOTECH ONE, INC.
    Date Cleared
    2006-02-15

    (76 days)

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

    KORLEX-GR GINGIVAL RETRACTION PASTE

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

    Korlex-GRTM is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures when sulcus widening is needed.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Biotech One, Incorporated, regarding their device Korlex-GR™. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request for the detailed table and study information based on this input. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also outlines general regulatory compliance requirements.

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