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

    DENTURE CLEANER

    K Number: K832387 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    55

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    Basic Information

    Device Name
    DENTURE CLEANER
    K Number
    K832387
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3530
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Tower Laboratories, Ltd.
    Date Received
    July 19, 1983
    Decision Date
    September 12, 1983
    Product Code
    JER
    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
    JER Cleaner, Denture, Mechanical

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