BEUDAMED
    Product Code: EKY FDA class 1 21 CFR 872.4200

    Handpiece, Water-Powered

    Dental

    The Water-Powered Dental Handpiece is a dental rotary instrument driven by the force of pressurized water flow rather than compressed air or electricity, providing a simple mechanical means of operating cutting instruments during dental procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKY, regulated under 21 CFR 872.4200 in the Dental (DE) specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    2
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    22

    Basic Information

    Product Code
    EKY
    Device Class
    FDA class 1
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K123695 TRAUS SIP10
    K896364 DECIDENT

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.