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

    CONCEPT II

    K Number: K790339 · Decision Jul 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    146

    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
    CONCEPT II
    K Number
    K790339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Richardson Merrel, Inc.
    Date Received
    February 21, 1979
    Decision Date
    July 17, 1979
    Product Code
    EBE
    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
    EBE Coating, Denture Hydrophilic, Resin

    Similar 510(k) Clearances

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

    CS-11

    FDA 510(k)
    FDA Class 2 ·Dental

    JOHNSON & JOHNSON OPAQUE COLOR MODIFI

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

    Other Clearances by Richardson Merrel, Inc.

    K Number Device Name
    K780254 DENTURE CLEANSER & TOOTHPASTE IN ONE