BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    Dental Handpiece

    K Number: K192809 · Decision Aug 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    24
    Applicant Total
    7
    Review Days
    329

    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
    Dental Handpiece
    K Number
    K192809
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Nx Co., Ltd.
    Date Received
    October 1, 2019
    Decision Date
    August 25, 2020
    Product Code
    EFA
    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
    EFA Handpiece, Belt And/Or Gear Driven, Dental

    Similar 510(k) Clearances

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

    SMARTmatic

    FDA 510(k)
    FDA Class 1 ·Dental

    MASTERmatic LUX

    FDA 510(k)
    FDA Class 1 ·Dental

    RDT3 HANDPIECE HEAD MODEL RDT3

    FDA 510(k)
    FDA Class 1 ·Dental

    ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE

    FDA 510(k)
    FDA Class 1 ·Dental

    INTRA LUX HEAD 3 LDSY

    FDA 510(k)
    FDA Class 1 ·Dental

    LOW & HIGH SPEED KIT

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

    Other Clearances by Micro-Nx Co., Ltd.

    K Number Device Name
    K231562 ELEC ENGINE (Model: ISE-170L)
    K232810 Dental Handpiece, Wireless Endodontic Handpiece, endoit
    K220577 Dental Handpiece, Model CA160, CA160L, and CA500L
    K201191 ELEC-LED
    K201192 Impla-NX (Model: ISE-270M)
    K161500 MEG-TORQ