BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FLOSSAGE - ELECTRIC TOOTHFLOSSER

    K Number: K850562 · Decision Mar 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    343
    Registration Numbers
    344
    Same Product Code
    53
    Applicant Total
    1
    Review Days
    43

    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
    FLOSSAGE - ELECTRIC TOOTHFLOSSER
    K Number
    K850562
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6865
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Mcspadden, Inc.
    Date Received
    February 12, 1985
    Decision Date
    March 27, 1985
    Product Code
    JEQ
    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
    JEQ Toothbrush, Powered

    Similar 510(k) Clearances

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

    Oral-B iO Test Drive Power Brush Trial Program Kit

    FDA 510(k)
    FDA Class 1 ·Dental

    ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT

    FDA 510(k)
    FDA Class 1 ·Dental

    ORAL-B SONIC COMPLETE

    FDA 510(k)
    FDA Class 1 ·Dental

    ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES

    FDA 510(k)
    FDA Class 1 ·Dental

    SONICARE ADVANCE TOOTHBRUSH, MODEL 4900

    FDA 510(k)
    FDA Class 1 ·Dental

    BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES

    FDA 510(k)
    FDA Class 1 ·Dental
    View all