BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PERFECT TISSUE CONTOURING SYSTEM II

    K Number: K071632 · Decision Oct 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    18
    Applicant Total
    21
    Review Days
    126

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    Basic Information

    Device Name
    PERFECT TISSUE CONTOURING SYSTEM II
    K Number
    K071632
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.4920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coltene/Whaledent, Inc.
    Date Received
    June 14, 2007
    Decision Date
    October 18, 2007
    Product Code
    EKZ
    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
    EKZ Unit, Electrosurgical, And Accessories, Dental

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