BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CLICK-IT

    K Number: K111234 · Decision May 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    59
    Applicant Total
    5
    Review Days
    11

    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
    CLICK-IT
    K Number
    K111234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tp Orthodontics, Inc.
    Date Received
    May 2, 2011
    Decision Date
    May 13, 2011
    Product Code
    NJM
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NJM Bracket, Ceramic, Orthodontic

    Similar 510(k) Clearances

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

    LightForce Orthodontic System

    FDA 510(k)
    FDA Class 2 ·Dental

    Cleo

    FDA 510(k)
    FDA Class 2 ·Dental

    A-Line Advanced

    FDA 510(k)
    FDA Class 2 ·Dental

    DynaFlex Clear Brackets & Buttons

    FDA 510(k)
    FDA Class 2 ·Dental

    Ceramic Brackets Orthometric

    FDA 510(k)
    FDA Class 2 ·Dental

    LightForce Orthodontic System

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

    Other Clearances by Tp Orthodontics, Inc.

    K Number Device Name
    K214054 TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
    K193385 TP Orthodontics Clear Aligner System
    K952643 RIGHT-ON ADHESIVE BOUDING SYSTEM
    K950992 CERAMAFLEX BRACKET SYSTEM