BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ENDOCEM Zr

    Reg #: 3009560600 · FEI: 3009560600 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MARUCHI
    Registration Number
    3009560600
    FEI Number
    3009560600
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101, Donghwagongdan-ro, Munmak-eup
    City
    Wonju-si Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K133042

    Owner / Operator

    Firm Name
    MARUCHI
    Operator Number
    10040294
    Address
    101, Donghwagongdan-ro, Munmak-eup
    City
    Wonju-si
    State
    Gangwon
    Postal Code
    26365
    Country
    KR
    Correspondent
    Sung-wook Jang

    US Agent

    Business Name
    KB Dental Products Inc
    Contact Name
    Kevin Bang
    Address
    1205 N Tustin Ave
    City
    Anaheim
    State
    CA
    ZIP
    92807
    Country
    US
    Email
    [email protected]
    Phone
    714 5975851

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF

    Proprietary Names

    ENDOCEM Zr

    Establishment Types

    Manufacture Medical Device