BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DENTIS MEDICAL DIVISION

    Reg #: 3010373494 · FEI: 3010373494 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    10

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    Registration Details

    Registration Name
    DENTIS MEDICAL DIVISION
    Registration Number
    3010373494
    FEI Number
    3010373494
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 Yuram-ro, Dong-gu,
    City
    Daegu
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K233921

    Owner / Operator

    Firm Name
    Dentis Co., Ltd.
    Operator Number
    10025697
    Address
    99, Seongseoseo-ro, Dalseo-gu
    City
    Daegu
    State
    KR-27
    Postal Code
    42718
    Country
    KR

    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
    Syringe, Cartridge EJI
    Table, Operating-Room, Electrical GDC
    Chair, Dental, Without Operative Unit NRU
    Chair, Dental, With Operative Unit KLC
    Unit, Operative Dental EIA
    Table, Operating-Room, Ac-Powered FQO
    Light, Operating, Dental EAZ
    Device, Medical Examination, Ac Powered KZF
    Handpiece, Direct Drive, Ac-Powered EKX
    Lamp, Surgical FTD

    Proprietary Names

    DENOPS ST300 ST300E ST500E ST500 Luvis Chair (LC700C-chair only plus) Luvis Chair (LC700C-chair only) Luvis Chair (LC700C) SA300 Series LUVIS-C200 Series LUVIS-C500 Series LUVIS-C100 Series LUVIS-C400 Series LUVIS-C300 Series LUVIS-C600 Series Medical LED Light (Luvis S) LUVIS-C700 Series E100 series(E1-M, E1-C, E1-W) S200 Series (Mobile, Ceiling, Dual Ceiling, Wall) L2S20-00210 (S200 Chair, S200 Dual Connection) ChecQ (AC100) M300 Series(Ceiling, Mobile) L200 Series (Ceiling, Mobile) M200 Series (Ceiling, Mobile) M310 Series(Ceiling, Mobile) M210 Series(Ceiling, Mobile) M400 Series (Ceiling, Mobile) L400 Series (Ceiling, Mobile) S300 series S250 Series(Ceiling, Mobile)

    Establishment Types

    Manufacture Medical Device