BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DIADENT GROUP INTERNATIONAL

    Reg #: 9616128 · FEI: 3010138769 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    54
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    DIADENT GROUP INTERNATIONAL
    Registration Number
    9616128
    FEI Number
    3010138769
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    16, Osongsaengmyeong 4-Ro, Osong-Eup, HEUNGDUKGU
    City
    CHONGJU CITY Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K192273

    Owner / Operator

    Firm Name
    DiaDent Group International
    Operator Number
    9033762
    Address
    16, Osongsaengmyeong 4-Ro, Osong-Eup,, Heungdeok-Gu
    City
    CHONGJU CITY
    State
    Chungbuk
    Postal Code
    28161
    Country
    KR

    US Agent

    Business Name
    USDeviceAgent.com
    Contact Name
    Jim MacNee
    Address
    31574 Flying Cloud Drive
    City
    Laguna Niguel
    State
    CA
    ZIP
    92677
    Country
    US
    Email
    [email protected]
    Phone
    951 8486626

    Products

    Device Name Product Code
    Tip, Rubber, Oral Hygiene JEW
    Agent, Tooth Bonding, Resin KLE
    Material, Tooth Shade, Resin EBF
    Resin, Root Canal Filling KIF
    Pick, Massaging JET
    Crown And Bridge, Temporary, Resin EBG
    Point, Paper, Endodontic EKN
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Cement, Dental EMA
    Plugger, Root Canal, Endodontic EKR
    Activator, Ultraviolet, For Polymerization EBZ
    Gutta-Percha EKM
    Zinc Oxide Eugenol EMB
    Preparer, Root Canal Endodontic EKQ
    Gauge, Depth, Instrument, Dental EIL
    Drill, Dental, Intraoral DZA
    File, Pulp Canal, Endodontic EKS
    Condenser, Amalgam And Foil, Operative EKG
    Mirror, Mouth EAX
    Instrument, Filling, Plastic, Dental EIY
    Broach, Endodontic EKW
    Applicator, Resin KXR

    Proprietary Names

    Steri. Irrigation Tips (Side Open Type) Disposable Tips Irrigation Tips (End Open Type) DiaPex Plus Dia-Ultrasonic DiaTemp ABSORBENT PAPER POINTS(STERII.E PAPER POINTS) Dia-100FS Dia-Cem Dia-Duo Duo-Gun Duo-Pen DIAFIL FLOW D-Lux+ DIA-PROSEAL DiaPaste DIAFIL START KIT DiaPlus DIA-ROOT BIO MTA GUTTA PERCHA POINTS GUTTA PERCHA OBTURATOR DIA-X BOND Universal DIACEM TEMPNE DiaPrep Pro DIA-ENDORING Endo Training Blocks Endo Shaping Blocks FILE MEASURE SET DIA-GP GAUGE ENDO STOPS DIRECTIONAL ASST DiaTemp Flow DIAFIL Bulk FLOW(Refill Package) DIAFIL Bulk FLOW (0.5g) DIAFIL Bulk FLOW Peeso Reamers Gate Drills DIA-ROOT BIO Sealer K-FILE (NICKEL-TITANIUM) Hedstrom Files H-FILE (NICKEL-TITANIUM) K-Files Reamers REAMER (NICKEL-TITANIUM) DIA-X FILE DIA-KONDENSOR DIAFIL Capsule Type DIAFIL Miracle Suction Disposable Brushes Barbed Broaches Brush Tips Mixing pad Mixing Well Brush Handle

    Establishment Types

    Foreign Private Label Distributor Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device