BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    OSSTEM ORTHODONTICS Inc.

    Reg #: 3006946041 · FEI: 3006946041 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    45
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    OSSTEM ORTHODONTICS Inc.
    Registration Number
    3006946041
    FEI Number
    3006946041
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    (Ojeon-dong, Byeoksantechnopia) A-1203, 1204, 13 Ojeongongeop-gil,
    City
    Uiwang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K112707

    Owner / Operator

    Firm Name
    OSSTEM ORTHODONTICS Inc.
    Operator Number
    10050607
    Address
    (Ojeon-dong, Byeoksantechnopia) A-1203, 1204, 13 Ojeongongeop-gil,
    City
    Uiwang-si
    State
    Gyeonggi
    Postal Code
    16072
    Country
    KR

    US Agent

    Business Name
    J.S.Chem International Co.
    Contact Name
    Grace Kim
    Address
    20155 Pingree Way
    City
    Yorba Linda
    State
    CA
    ZIP
    92887
    Country
    US
    Email
    [email protected]
    Phone
    310 5983012

    Products

    Device Name Product Code
    Band, Material, Orthodontic DYO
    Bracket, Ceramic, Orthodontic NJM
    Tube, Orthodontic DZD
    Bracket, Metal, Orthodontic EJF
    Strip, Polishing Agent EHM
    Wire, Orthodontic DZC
    Setter, Band, Orthodontic ECR
    Plier, Orthodontic JEX

    Proprietary Names

    FACEMASK BL Rev BK MASK violet BK MASK ivory BK MASK blue FACEMASK BL Org FACEMASK VI Org FACEMASK VI Rev Sensation Genesis- C Clear Elect MAJESTY-SLC Neocrystal Plus Pure MTA Silver Tube 3mm MTA One side flattened Tube MTA Round Tube MTA Silver Tube 2mm MTA Semi-Round Tube L-Tube 2mm LPA 027 tube 2mm L-Tube 3mm LPA 022 tube 3mm LPA 022 tube 1mm LPA 027 tube 3mm LPA 022 tube 2mm LPA 027 tube 1mm Sensation M YES2 MAJESTY-SLM SM Tube MAJESTY Tube Dr. Unbong's M-P Tube(Molar Protraction Tube) 650-12 Reducer Strip(One-side) 650-10 Reducer Strip(Thin) 650-09 Reducer Strip(Thick) 650-08 Perforated Strip MTA Wire 012 NiTi MTA Wire 014 NiTi MTA Wire 45celsius thermo-active 012 NiTi MTA Wire 40celsius thermo-active 012 NiTi MTA Wire 35celsius thermo-active 012 NiTi Forced Positioner R Forced Positioner L Step Bend Plier L Step Bend Plier R

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility