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

    DENDIA WERK BURS AND CUTTING DISCS

    K Number: K901967 · Decision Jul 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    20
    Applicant Total
    40
    Review Days
    73

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    Basic Information

    Device Name
    DENDIA WERK BURS AND CUTTING DISCS
    K Number
    K901967
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4535
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Micro-Aire Surgical Instruments, Inc.
    Date Received
    May 1, 1990
    Decision Date
    July 13, 1990
    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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