BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CSM Implant

    Reg #: 3005998060 · FEI: 3005998060 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    47
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CSM Implant
    Registration Number
    3005998060
    FEI Number
    3005998060
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B205, Techno B/D, Kyungpook University, 47, Gyeongdae-ro17-gil, Buk-gu
    City
    DAEGU
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K111120

    Owner / Operator

    Firm Name
    CSM Implant
    Operator Number
    9090832
    Address
    B205, Techno B/D, Kyungpook University, 47, Gyeongdae-ro17-gil, Buk-gu
    City
    Daegu
    State
    KR-27
    Postal Code
    702-832
    Country
    KR
    Correspondent
    Sung Am Cho

    US Agent

    Business Name
    Withus Group Inc.
    Contact Name
    April Lee
    Address
    106 Superior
    City
    Irvine
    State
    CA
    ZIP
    92620
    Country
    US
    Email
    [email protected]
    Phone
    909 2749971

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    implant1 CSM Submerged3-L Implant System Guide Driver Holder Fixture Analogue I-Drill Mountless Driver Twist Drill Mount Driver Stopper Stand Bone Condenser Retainer Impression Space Stopper Remover Screw Octa Abutment Impression Coping (Pick-up, Transfer) Guide Holder Torx Driver Wrench Adapter Fixture Remover Driver Stopper (Small, Big) Guide Driver Torque Wrench Countersink Octa Driver Guide Drill Reamer I-Drill Stopper Retainer Driver Tap Dummy Round Bur Depth Gauge Spreader Driver Impression Coping (Pick-up, Transfer) Octa Abutment Impression Coping Pin Drill Extension Guide Pin Tissue Punch Impression Coping Pin (Pick-up) Lindman Drill Remover Drill Retainer Impression Plastic Male Trephine Drill Solid Driver Octa Abutment Analogue Bone Carrier implant2 implant3

    Establishment Types

    Manufacture Medical Device