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

    DENTAL DIAMOND BURS

    K Number: K871639 · Decision May 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    20
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    DENTAL DIAMOND BURS
    K Number
    K871639
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4535
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    E&D Dental Manufacturing Co.
    Date Received
    April 27, 1987
    Decision Date
    May 18, 1987
    Product Code
    DZP
    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
    DZP Instrument, Diamond, Dental

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    Other Clearances by E&D Dental Manufacturing Co.

    K Number Device Name
    K883698 ZINC OXIDE EUGENOL TEMPORARY CEMENT
    K873739 ACRYLIC IMPRESSION TRAY MATERIALS
    K873738 ACRYLIC BASE DENTURE MATERIALS
    K864922 DENTAL HANDPIECES AND ATTACHMENT
    K862745 EUGENOL USP