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

    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

    K Number: K250473 · Decision Feb 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    281
    Applicant Total
    1
    Review Days
    —

    Basic Information

    Device Name
    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
    K Number
    K250473
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DCI International LLC
    Date Received
    February 19, 2025
    Decision Date
    February 19, 2025
    Product Code
    EIA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EIA Unit, Operative Dental

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