BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    KORLEX-GR GINGIVAL RETRACTION PASTE

    K Number: K053329 · Decision Feb 15, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    KORLEX-GR GINGIVAL RETRACTION PASTE
    K Number
    K053329
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biotech One, Inc.
    Date Received
    December 1, 2005
    Decision Date
    February 15, 2006
    Product Code
    MVL
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MVL Cord, Retraction

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