BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INSTA-GLAZE

    K Number: K854588 · Decision Feb 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    INSTA-GLAZE
    K Number
    K854588
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6030
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    George Taub Products & Fusion Co., Inc.
    Date Received
    November 18, 1985
    Decision Date
    February 4, 1986
    Product Code
    EJR
    Advisory Committee
    Dental
    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
    EJR Agent, Polishing, Abrasive, Oral Cavity

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