BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    OraCare (Models: CR12, OB23, OB53)

    Reg #: 3016096134 · FEI: 3016096134 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TBM CORPORATION
    Registration Number
    3016096134
    FEI Number
    3016096134
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B-301, 313, Cheomdangwagi-ro,
    City
    Buk-gu, Gwangju
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K183436

    Owner / Operator

    Firm Name
    TBM Corporation
    Operator Number
    10061533
    Address
    B-301, 313, Cheomdangwagi-ro,
    City
    Buk-gu,
    State
    Gwangju
    Postal Code
    61008
    Country
    KR
    Correspondent
    Jaewoong Jung

    US Agent

    Business Name
    INNO SENSE, INC.
    Contact Name
    RYAN HWANG
    Address
    210 SYLVAN AVENUE SUITE 24
    City
    Englewd Clfs
    State
    NJ
    ZIP
    07632
    Country
    US
    Email
    [email protected]
    Phone
    201 4319052

    Products

    Device Name Product Code
    Oral Wound Dressing OLR

    Proprietary Names

    OraCare (Models: CR12, OB23, OB53) Canker Relief (Model: CR12) Curatick (Models: CR12, CR23, CR53)

    Establishment Types

    Manufacture Medical Device