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

    MODIFIED PERMAGUM ADHESIVE

    K Number: K881838 · Decision Jul 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    29
    Applicant Total
    59
    Review Days
    86

    Basic Information

    Device Name
    MODIFIED PERMAGUM ADHESIVE
    K Number
    K881838
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3670
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    ESPE GMBH (US)
    Date Received
    May 2, 1988
    Decision Date
    July 27, 1988
    Product Code
    EBH
    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
    EBH Material, Impression Tray, Resin

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    Search all 59 clearances from ESPE GMBH (US) →