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

    I-TEC PORTABLE DENTAL OPERATORY

    K Number: K040153 · Decision May 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    I-TEC PORTABLE DENTAL OPERATORY
    K Number
    K040153
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Indigenous Peoples Technology and Education Center
    Date Received
    January 23, 2004
    Decision Date
    May 21, 2004
    Product Code
    EBW
    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
    EBW Controller, Foot, Handpiece And Cord

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