BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MARUCHI

    Reg #: 3009560600 · FEI: 3009560600 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    MARUCHI
    Registration Number
    3009560600
    FEI Number
    3009560600
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101, Donghwagongdan-ro, Munmak-eup
    City
    Wonju-si Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K213757

    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
    Needle, Dental DZM
    Resin, Root Canal Filling KIF
    File, Pulp Canal, Endodontic EKS
    Liner, Cavity, Calcium Hydroxide EJK
    Pick, Massaging JET

    Proprietary Names

    AH Plus® Bioceramic Sealer Endodontic Cannulas SendoCem MTA ENDOCEM MTA PREMIXED REGULAR AH Plus® Bioceramic Sealer White ENDOSEAL MTA White ENDOSEAL Bioceramic Sealer EndoSonic Metal ENDOSONIC BLUE Ni-Ti File ENDOSONIC BLUE Ni-Ti File 2 ENDOSONIC BLUE PLUS ENDOSONIC BLUE EndoRoad EndoRoad S EndoRoad N EndoRoad P VPT Orifice Shaper ENDOSONIC BLUE EMS PP file ENDOSEAL MTA ENDOSEAL BIOCERAMIC SEALER SendoSeal MTA CleaniCal ENDOSONIC BLUE KIT ENDOSONIC BLUE PORTABLE ENDOCEM MTA

    Establishment Types

    Manufacture Medical Device