BEUDAMED
    FDA Registration Inactive 🇰🇷 South Korea

    OSSTEM IMPLANT CO.,LTD.

    · Expires 2026
    Products
    6
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    OSSTEM IMPLANT CO.,LTD.
    Status
    Inactive
    Expiry Year
    2026
    Initial Importer
    No
    Address
    104 Cheomdan-daero
    City
    Yeonsu-gu Incheon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K232012

    Owner / Operator

    Firm Name
    Osstem Implant Co.,Ltd.
    Operator Number
    10095871
    Address
    104 Cheomdan-daero
    City
    Yeonsu-gu
    State
    Incheon
    Postal Code
    21989
    Country
    KR
    Correspondent
    Hae Sung Kim

    Products

    Device Name Product Code
    Unit, X-Ray, Extraoral With Timer EHD
    X-Ray, Tomography, Computed, Dental OAS
    Chair, Dental, With Operative Unit KLC
    Unit, Operative Dental EIA
    Chair, Dental, Without Operative Unit NRU
    Unit, X-Ray, Intraoral EAP

    Proprietary Names

    N1 T2 Plus (T2-C-P, T2-CS-P) K5 K3-Chair only T1 C, T1-CS K3 K5 Cart, K5 Mount, K5 Swing T2 (T2-C, T2-CS) S2 (digital intra-oral X-ray sensor)

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device