BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ODONTOSURGE 2

    K Number: K981390 · Decision Jun 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    56

    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
    ODONTOSURGE 2
    K Number
    K981390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Periogiene
    Date Received
    April 16, 1998
    Decision Date
    June 11, 1998
    Product Code
    EKZ
    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
    EKZ Unit, Electrosurgical, And Accessories, Dental

    Similar 510(k) Clearances

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

    Root ZX3

    FDA 510(k)
    FDA Class 2 ·Dental

    PERFECT TISSUE CONTOURING SYSTEM II

    FDA 510(k)
    FDA Class 2 ·Dental

    THE FUGO BLADE FOR DENTISTRY

    FDA 510(k)
    FDA Class 2 ·Dental

    MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    MC6A

    FDA 510(k)
    FDA Class 2 ·Dental

    X O ODONTOSURGE 4

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