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

    IMPLANT HANDPIECES

    K Number: K051661 · Decision Sep 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    42
    Review Days
    76

    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
    IMPLANT HANDPIECES
    K Number
    K051661
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sirona Dental Systems GmbH
    Date Received
    June 22, 2005
    Decision Date
    September 6, 2005
    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 Sirona Dental Systems GmbH

    K Number Device Name
    K160099 CEREC SpeedGlaze
    K151045 TENEO Dental Treatment Unit and Accessories
    K150909 INTEGO Family and Accesories
    K150750 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
    K150217 ORTHOPHOS SL
    K131319 T1/T2/T3 TURBINE FAMILY
    K132773 SIDEXIS 4
    K123664 INCORIS ZI
    K123952 CEREC BLOCS C IN
    K123070 GALILEOS FAMILY
    Search all 42 clearances from Sirona Dental Systems GmbH →