BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FASTBRACES® CLASSIC™ CLEAR LR3

    Reg #: 3009402818 · FEI: 3009402818 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTHOWORLD, L.L.C.
    Registration Number
    3009402818
    FEI Number
    3009402818
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2670 FM 983
    City
    Red Oak
    State
    TX
    ZIP
    75154
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130446

    Owner / Operator

    Firm Name
    Orthoworld, L.L.C.
    Operator Number
    10038866
    Address
    2670 FM 983
    City
    Red Oak
    State
    TX
    Postal Code
    75154
    Country
    US
    Correspondent
    Anthony D Viazis

    Products

    Device Name Product Code
    Bracket, Ceramic, Orthodontic NJM

    Proprietary Names

    FASTBRACES® CLASSIC™ CLEAR LR3 Fastbraces® Combo-Turbo™ Bracket Kit Fastbraces® Clear Bracket Kit FASTBRACES® CLASSIC™ CLEAR UR1 FASTBRACES® CLASSIC™ CLEAR LL/LR 1/2 FASTBRACES® CLASSIC™ CLEAR UL1 FASTBRACES® CLASSIC™ CLEAR U/L 4/5 FASTBRACES® CLASSIC™ CLEAR UR3 FASTBRACES® CLASSIC™ CLEAR UL3 FASTBRACES® CLASSIC™ CLEAR LL3 FASTBRACES® CLASSIC™ CLEAR UR2 Fastbraces® Combo Bracket Kit FASTBRACES® CLASSIC™ CLEAR UL2

    Establishment Types

    Repack or Relabel Medical Device