BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    EM-07 Cordless Endo Motor

    K Number: K232551 · Decision Jul 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    2
    Review Days
    321

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EM-07 Cordless Endo Motor
    K Number
    K232551
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Forum Engineering Technologies (96) , Ltd.
    Date Received
    August 23, 2023
    Decision Date
    July 9, 2024
    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

    EnDrive (EnDriveUS)

    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
    View all

    Other Clearances by Forum Engineering Technologies (96) , Ltd.

    K Number Device Name
    K111474 BINGO PRO