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

    ULTRASONIC DENTURE CLEANER

    K Number: K881391 · Decision Aug 26, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    144

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    Basic Information

    Device Name
    ULTRASONIC DENTURE CLEANER
    K Number
    K881391
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3530
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Tatung Company of America, Inc.
    Date Received
    April 4, 1988
    Decision Date
    August 26, 1988
    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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    Other Clearances by Tatung Company of America, Inc.

    K Number Device Name
    K874805 TATUNG'S DENTURE CLEANING SOLUTION