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

    W&H Implantmed SI-1015 incl. Accessories

    K Number: K161957 · Decision Nov 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    128

    Basic Information

    Device Name
    W&H Implantmed SI-1015 incl. Accessories
    K Number
    K161957
    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 BURMOOS GMBH
    Date Received
    July 18, 2016
    Decision Date
    November 23, 2016
    Product Code
    EBW
    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
    EBW Controller, Foot, Handpiece And Cord

    Similar 510(k) Clearances

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

    Dental Implant Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    NLZ Built-In Motor System

    FDA 510(k)
    FDA Class 1 ·Dental

    Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)

    FDA 510(k)
    FDA Class 1 ·Dental

    CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,

    FDA 510(k)
    FDA Class 1 ·Dental

    Fiber Optic Brushless Electronic Micromotor, model: iM100

    FDA 510(k)
    FDA Class 1 ·Dental

    Implanter incl. Accessories

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

    Other Clearances by W&H DENTALWERK BURMOOS GMBH

    K Number Device Name
    K162926 Air-Powered Handpieces and Handpiece Attachments