BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    EnDrive (EnDriveUS)

    K Number: K243692 · Decision Aug 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    2
    Review Days
    266

    Basic Information

    Device Name
    EnDrive (EnDriveUS)
    K Number
    K243692
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Technology Research (A.T.R.) S.R.L.
    Date Received
    November 29, 2024
    Decision Date
    August 22, 2025
    Product Code
    EKX
    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
    EKX Handpiece, Direct Drive, Ac-Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EKX), ordered by most recent decision date.

    Alpha Endo Handpiece (Alpha Endo)

    FDA 510(k)
    FDA Class 1 ·Dental

    InnerView System

    FDA 510(k)
    FDA Class 1 ·Dental

    Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

    FDA 510(k)
    FDA Class 1 ·Dental

    ChecQ (AC100)

    FDA 510(k)
    FDA Class 1 ·Dental

    HPR Cordless Hygiene Handpiece

    FDA 510(k)
    FDA Class 1 ·Dental

    The Trust

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Advanced Technology Research (A.T.R.) S.R.L.

    K Number Device Name
    K033597 ATR 5000, LC 5000, IMPLANT SYSTEM