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

    PS System

    K Number: K211721 · Decision Dec 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    181

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    Basic Information

    Device Name
    PS System
    K Number
    K211721
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inter-Med, Inc.
    Date Received
    June 4, 2021
    Decision Date
    December 2, 2021
    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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