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

    ADVANCED DENTURE SYSTEM

    K Number: K780722 · Decision May 26, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    25

    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
    ADVANCED DENTURE SYSTEM
    K Number
    K780722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3600
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Advanced Marketing Research Co.
    Date Received
    May 1, 1978
    Decision Date
    May 26, 1978
    Product Code
    EKO
    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
    EKO Denture Preformed (Partially Prefabricated Denture)

    Similar 510(k) Clearances

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

    DENE BRIDGE

    FDA 510(k)
    FDA Class 2 ·Dental

    DENTAL ROOT ELEVATOR

    FDA 510(k)
    FDA Class 2 ·Dental

    FLEXIDENT DENTURE

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