BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FAIRFIELD ORTHODONTICS, LLC

    Reg #: 3006291983 · FEI: 3006291983 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    8

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    Registration Details

    Registration Name
    FAIRFIELD ORTHODONTICS, LLC
    Registration Number
    3006291983
    FEI Number
    3006291983
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    410 SURF AVENUE
    City
    STRATFORD
    State
    CT
    ZIP
    06615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091702

    Owner / Operator

    Firm Name
    FAIRFIELD ORTHODONTICS, LLC
    Operator Number
    9101523
    Address
    410 SURF AVENUE, --
    City
    Stratford
    State
    CT
    Postal Code
    06615
    Country
    US
    Correspondent
    NICHOLAS - LULKA

    Products

    Device Name Product Code
    Bracket, Ceramic, Orthodontic NJM
    Bracket, Metal, Orthodontic EJF
    Band, Elastic, Orthodontic ECI
    Tube, Orthodontic DZD
    Plier, Orthodontic JEX
    Band, Preformed, Orthodontic ECM
    Wire, Orthodontic DZC
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    SMILES CERAMIC BRACKETS GEM PLUS BRACKETS STRATUS BRACKETS LP GEM BRACKETS ELASTICS ELASTOTIES ELASTOMERIC TIES FAIRFIELD BUCCAL TUBES ANCHOR BUCCAL TUBE PERFORMA INSTRUMENTS TITAN MOLAR BANDS FAIRFIELD BANDS BEST FIT MOLAR BANDS TIBEND WIRE SS WIRE NITI WIRE PERFORMA ADHEVISE

    Establishment Types

    Repack or Relabel Medical Device