BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ULTRAFINE TRAY ADHESIVE

    K Number: K820489 · Decision Mar 19, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    399
    Applicant Total
    11
    Review Days
    24

    Basic Information

    Device Name
    ULTRAFINE TRAY ADHESIVE
    K Number
    K820489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    BUFFALO DENTAL MFG. CO., INC.
    Date Received
    February 23, 1982
    Decision Date
    March 19, 1982
    Product Code
    ELW
    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
    ELW Material, Impression

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