BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHODENTALUSA CORP.

    Reg #: 3007962015 · FEI: 3007962015 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    16

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    Registration Details

    Registration Name
    ORTHODENTALUSA CORP.
    Registration Number
    3007962015
    FEI Number
    3007962015
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1500 Weston Rd Ste 204
    City
    Weston
    State
    FL
    ZIP
    33326
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130410

    Owner / Operator

    Firm Name
    ORTHODENTALUSA CORP.
    Operator Number
    10031414
    Address
    1500 weston Rd., Suite 204
    City
    Weston
    State
    FL
    Postal Code
    33326
    Country
    US
    Correspondent
    Luis F Cardenas

    Products

    Device Name Product Code
    Band, Material, Orthodontic DYO
    Instrument, Ligature Tucking, Orthodontic ECP
    Bracket, Metal, Orthodontic EJF
    Unit, Operative Dental EIA
    Retainer, Screw Expansion, Orthodontic DYJ
    Plier, Orthodontic JEX
    Aligner, Bracket, Orthodontic ECQ
    Band, Preformed, Orthodontic ECM
    Spring, Orthodontic ECO
    Maintainer, Space Preformed, Orthodontic DYT
    Pusher, Band, Orthodontic ECS
    Tube, Orthodontic DZD
    Band, Elastic, Orthodontic ECI
    Wire, Orthodontic DZC
    Scaler, Ultrasonic ELC
    Setter, Band, Orthodontic ECR

    Proprietary Names

    KASO MEDICAL TECHNOLOGY Co., LTD ORTHODENTALUSA CORP

    Establishment Types

    Repack or Relabel Medical Device