BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    OssGuide

    Reg #: 3017847628 · FEI: 3017847628 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HYUNDAI BIOLAND CO., LTD.
    Registration Number
    3017847628
    FEI Number
    3017847628
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu
    City
    Cheongju-si Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200623

    Owner / Operator

    Firm Name
    HYUNDAI BIOLAND Co., Ltd.
    Operator Number
    10078950
    Address
    162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu
    City
    Cheongju-si
    State
    Chungbuk
    Postal Code
    28125
    Country
    KR
    Correspondent
    Hee Joon Lee

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Barrier, Animal Source, Intraoral NPL

    Proprietary Names

    OssGuide XP-SEAL OsseoSeal OsteoFlex Oradapt T-Gen TBS Dental

    Establishment Types

    Manufacture Medical Device