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

    Star E900 Electric System

    K Number: K251701 · Decision Jan 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    224

    Basic Information

    Device Name
    Star E900 Electric System
    K Number
    K251701
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentalez, Inc., Stardental Division
    Date Received
    June 2, 2025
    Decision Date
    January 12, 2026
    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.

    Motor Handpiece and Control Unit (SDI10)

    FDA 510(k)
    FDA Class 1 ·Dental

    Motor and Apex Module (MaAM)

    FDA 510(k)
    FDA Class 1 ·Dental

    ELEC ENGINE (Model: ISE-170L)

    FDA 510(k)
    FDA Class 1 ·Dental

    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
    View all

    Other Clearances by Dentalez, Inc., Stardental Division

    K Number Device Name
    K240183 Star E900 Handpiece Series