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

    ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM

    K Number: K140685 · Decision Jul 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    106

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    Basic Information

    Device Name
    ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
    K Number
    K140685
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sybron Endo
    Date Received
    March 18, 2014
    Decision Date
    July 2, 2014
    Product Code
    NYL
    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
    NYL Handpiece, Air-Powered, Root Canal Irrigation

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