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

    ZINC OXIDE EUGENOL TEMPORARY CEMENT

    K Number: K883698 · Decision Nov 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    ZINC OXIDE EUGENOL TEMPORARY CEMENT
    K Number
    K883698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    E&D Dental Manufacturing Co.
    Date Received
    August 30, 1988
    Decision Date
    November 29, 1988
    Product Code
    EMA
    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
    EMA Cement, Dental

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    Other Clearances by E&D Dental Manufacturing Co.

    K Number Device Name
    K873739 ACRYLIC IMPRESSION TRAY MATERIALS
    K873738 ACRYLIC BASE DENTURE MATERIALS
    K871639 DENTAL DIAMOND BURS
    K864922 DENTAL HANDPIECES AND ATTACHMENT
    K862745 EUGENOL USP