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

    Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L

    K Number: K150076 · Decision Jun 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    48
    Applicant Total
    2
    Review Days
    139

    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
    Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
    K Number
    K150076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dong IL Technology , Ltd.
    Date Received
    January 14, 2015
    Decision Date
    June 2, 2015
    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

    TRAUS SUS20

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

    Other Clearances by Dong IL Technology , Ltd.

    K Number Device Name
    K110881 ULTRASONIC SURGICAL UNIT