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

    EUGENOL USP

    K Number: K862745 · Decision Jul 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    10

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    Basic Information

    Device Name
    EUGENOL USP
    K Number
    K862745
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    E&D Dental Manufacturing Co.
    Date Received
    July 21, 1986
    Decision Date
    July 31, 1986
    Product Code
    EMB
    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
    EMB Zinc Oxide Eugenol

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    Other Clearances by E&D Dental Manufacturing Co.

    K Number Device Name
    K883698 ZINC OXIDE EUGENOL TEMPORARY CEMENT
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    K873738 ACRYLIC BASE DENTURE MATERIALS
    K871639 DENTAL DIAMOND BURS
    K864922 DENTAL HANDPIECES AND ATTACHMENT