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

    DIGIGRAPH DIAGNOSTIC WORK/STATION

    K Number: K896099 · Decision Jan 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    468

    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
    DIGIGRAPH DIAGNOSTIC WORK/STATION
    K Number
    K896099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1830
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dolphin Imaging Systems
    Date Received
    October 20, 1989
    Decision Date
    January 31, 1991
    Product Code
    EAG
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EAG Cephalometer

    Similar 510(k) Clearances

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

    VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC

    FDA 510(k)
    FDA Class 2 ·Dental

    VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY

    FDA 510(k)
    FDA Class 2 ·Dental

    DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GX-C CEPHALOMETER

    FDA 510(k)
    FDA Class 2 ·Dental

    BURNETT TMJ APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    GX CEPH

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