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

    ORTHODONTIC ELASTOMERIC CHAIN

    K Number: K943420 · Decision May 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    24
    Applicant Total
    5
    Review Days
    312

    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
    ORTHODONTIC ELASTOMERIC CHAIN
    K Number
    K943420
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jon-Ko Products, Inc.
    Date Received
    July 15, 1994
    Decision Date
    May 23, 1995
    Product Code
    ECI
    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
    ECI Band, Elastic, Orthodontic

    Similar 510(k) Clearances

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

    POWER COINS GLOW IN THE DARK LIGATURES

    FDA 510(k)
    FDA Class 1 ·Dental

    GLENROE CHAIN

    FDA 510(k)
    FDA Class 1 ·Dental

    GLENROE GLOW IN DARK ELASTOMERIC LIGATURES

    FDA 510(k)
    FDA Class 1 ·Dental

    ORTHODONTIC ELASTOMERIC LAGATURE MODULE

    FDA 510(k)
    FDA Class 1 ·Dental

    ORTHODONTIC ELASTOMERIC TUBE/THREAD

    FDA 510(k)
    FDA Class 1 ·Dental

    ORTHODONTIC ELASTOMERIC SEPARATOR MODULE

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

    Other Clearances by Jon-Ko Products, Inc.

    K Number Device Name
    K943419 ORTHODONTIC ELASTOMERIC LAGATURE MODULE
    K943417 ORTHODONTIC ELASTOMERIC TUBE/THREAD
    K943421 ORTHODONITC ELASTOMERIC SLEEVING
    K943418 ORTHODONTIC ELASTOMERIC SEPARATOR MODULE