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

    CLEAN UP

    K Number: K922985 · Decision May 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    2
    Review Days
    339

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    Basic Information

    Device Name
    CLEAN UP
    K Number
    K922985
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Probe, Inc.
    Date Received
    June 22, 1992
    Decision Date
    May 27, 1993
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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