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

    DENTAL ROOT ELEVATOR

    K Number: K892255 · Decision May 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    3
    Applicant Total
    76
    Review Days
    27

    Basic Information

    Device Name
    DENTAL ROOT ELEVATOR
    K Number
    K892255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3600
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    ZINNANTI SURGICAL INSTRUMENTS, INC.
    Date Received
    April 4, 1989
    Decision Date
    May 1, 1989
    Product Code
    EKO
    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
    EKO Denture Preformed (Partially Prefabricated Denture)

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