BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DENTIS MEDICAL DIVISION

    Reg #: 3033509587 · FEI: 3033509587 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    DENTIS MEDICAL DIVISION
    Registration Number
    3033509587
    FEI Number
    3033509587
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    F1, 102, 87, Yuram-ro
    City
    Dong-gu Daegu
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K241065

    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
    Handpiece, Direct Drive, Ac-Powered EKX
    Chair, Dental, With Operative Unit KLC
    Unit, Operative Dental EIA
    Chair, Dental, Without Operative Unit NRU

    Proprietary Names

    ChecQ (AC100) Luvis Chair (LC700C) Luvis Chair (LC700C-chair only plus) Luvis Chair (LC700C-chair only)

    Establishment Types

    Manufacture Medical Device