BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CHIC Brackets

    Reg #: 3010032042 · FEI: 3010032042 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    GC Orthodontics America Inc.
    Registration Number
    3010032042
    FEI Number
    3010032042
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3737 W. 127th Street
    City
    Alsip
    State
    IL
    ZIP
    60803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123094

    Owner / Operator

    Firm Name
    GC Orthodontics
    Operator Number
    10043100
    Address
    GC Orthodontics Inc., 3737 W. 127th Street
    City
    Alsip
    State
    IL
    Postal Code
    60803
    Country
    US

    Products

    Device Name Product Code
    Bracket, Ceramic, Orthodontic NJM

    Proprietary Names

    CHIC Brackets

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device