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

    ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)

    K Number: K895854 · Decision Apr 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    102
    Applicant Total
    5
    Review Days
    188

    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
    ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)
    K Number
    K895854
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Acme-Monaco Corp.
    Date Received
    October 3, 1989
    Decision Date
    April 9, 1990
    Product Code
    EJF
    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
    EJF Bracket, Metal, Orthodontic

    Similar 510(k) Clearances

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

    BITEM LOCK, MODELS SW006, SW012

    FDA 510(k)
    FDA Class 1 ·Dental

    MICROARCH GOLD BRACKET

    FDA 510(k)
    FDA Class 1 ·Dental

    ALASTIK

    FDA 510(k)
    FDA Class 1 ·Dental

    MEMORY WIRE

    FDA 510(k)
    FDA Class 1 ·Dental

    ORTHOTECH DURA-GOLD BARCKETS

    FDA 510(k)
    FDA Class 1 ·Dental

    FASCINATION CERAMIC BRACKET

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

    Other Clearances by Acme-Monaco Corp.

    K Number Device Name
    K113162 SLIDEWIRETM(TRADEMARK PENDING)
    K920884 GUIDEWIRES, VARIOUS TYPES
    K895483 ACME COATED ORTHODONTIC ARCHWIRE
    K883763 ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH