BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇹 Austria

    Synea Fusion Handpieces (Intensiv & Profin)

    K Number: K242179 · Decision Feb 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    1
    Review Days
    218

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    Basic Information

    Device Name
    Synea Fusion Handpieces (Intensiv & Profin)
    K Number
    K242179
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W&H Dentalwerk Bürmoos GmbH
    Date Received
    July 25, 2024
    Decision Date
    February 28, 2025
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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