BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    TRAUS SUS20

    K Number: K192561 · Decision Jul 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    48
    Applicant Total
    18
    Review Days
    300

    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
    TRAUS SUS20
    K Number
    K192561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Saeshin Precision Co., Ltd.
    Date Received
    September 17, 2019
    Decision Date
    July 13, 2020
    Product Code
    DZI
    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
    DZI Drill, Bone, Powered

    Similar 510(k) Clearances

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

    Implantmed Plus II & Piezomed Plus II Module

    FDA 510(k)
    FDA Class 2 ·Dental

    VarioSurg 4

    FDA 510(k)
    FDA Class 2 ·Dental

    MT-Bone

    FDA 510(k)
    FDA Class 2 ·Dental

    Surgical Drive System (Model: ES70, ES90, E8)

    FDA 510(k)
    FDA Class 2 ·Dental

    Guided Surgery Kit

    FDA 510(k)
    FDA Class 2 ·Dental

    Surgical Drills

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Saeshin Precision Co., Ltd.

    K Number Device Name
    K251407 Motor Handpiece and Control Unit (SDI10)
    K233153 Traus SSG10 Surgical System
    K232938 Traus SSG30 Surgical System
    K221741 TRAUS Air Dental Handpiece
    K212043 TRAUS ENDO
    K201292 TRAUS SIP20
    K182892 TRAUS Dental Handpieces
    K181129 STRONG Dental Handpieces
    K171436 STRONG Dental Handpieces
    K151171 TRAUS SUS10
    Search all 18 clearances from Saeshin Precision Co., Ltd. →