BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    ORTHODONTIC POLYMER COMPOSITE BRACKET

    K Number: K053055 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    52

    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 POLYMER COMPOSITE BRACKET
    K Number
    K053055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gestenco International AB
    Date Received
    October 31, 2005
    Decision Date
    December 22, 2005
    Product Code
    DYW
    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
    DYW Bracket, Plastic, Orthodontic

    Similar 510(k) Clearances

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

    Carriere® Motion Pro® Clear Bite Corrector

    FDA 510(k)
    FDA Class 2 ·Dental

    Composite Orthodontic Brackets and Buttons

    FDA 510(k)
    FDA Class 2 ·Dental

    Braces on Demand Bracket

    FDA 510(k)
    FDA Class 2 ·Dental

    Blue Sky Bio Computerized Orthodontic Bracket System

    FDA 510(k)
    FDA Class 2 ·Dental

    ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Dental

    Carriere Motion Clear Class II

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