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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2

    K Number: K033198 · Decision Apr 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    5
    Review Days
    211

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    Basic Information

    Device Name
    APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
    K Number
    K033198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apoza Enterprise Co., Ltd.
    Date Received
    October 2, 2003
    Decision Date
    April 30, 2004
    Product Code
    ELC
    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
    ELC Scaler, Ultrasonic

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    Other Clearances by Apoza Enterprise Co., Ltd.

    K Number Device Name
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    K040618 LED TURBO
    K033201 LA500 BLUE LIGHT