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

    VATEA ENDONTIC IRRIGATION SYSTEM

    K Number: K100606 · Decision May 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    VATEA ENDONTIC IRRIGATION SYSTEM
    K Number
    K100606
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Redent Nova, Ltd.
    Date Received
    March 3, 2010
    Decision Date
    May 28, 2010
    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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