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

    GLENROE CHAIN

    K Number: K980053 · Decision Feb 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    24
    Applicant Total
    8
    Review Days
    49

    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
    GLENROE CHAIN
    K Number
    K980053
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Glenroe Technologies
    Date Received
    January 6, 1998
    Decision Date
    February 24, 1998
    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 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 CHAIN

    FDA 510(k)
    FDA Class 1 ·Dental

    ORTHODONTIC ELASTOMERIC SEPARATOR MODULE

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

    Other Clearances by Glenroe Technologies

    K Number Device Name
    K945535 GLENROE ORTHO-SIL
    K924351 GLENROE ELASTIBITE STIMULATOR
    K932920 GLENROE PLASTIC BRACKET
    K924140 TUFF TIES
    K924139 GLENROE ORTHO SEPS
    K924211 EJECTOR
    K924993 GLENROE BAND SEATING CONTOURING INSTRUMENT