BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Graphy Inc.

    Reg #: 3015302693 · FEI: 3015302693 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    Graphy Inc.
    Registration Number
    3015302693
    FEI Number
    3015302693
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #601, #603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K233502

    Owner / Operator

    Firm Name
    Graphy, Inc.
    Operator Number
    10061702
    Address
    #603, #617 Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    08501
    Country
    KR
    Correspondent
    Un-seob Sim

    US Agent

    Business Name
    SMB USA LLC.
    Contact Name
    HUICHAO LEE
    Address
    44855 LAFAYETTE DR
    City
    NOVI
    State
    MI
    ZIP
    48377
    Country
    US
    Email
    [email protected]
    Phone
    734 3671285

    Products

    Device Name Product Code
    Positioner, Tooth, Preformed KMY
    Crown And Bridge, Temporary, Resin EBG
    Material, Tooth Shade, Resin EBF
    Protector, Dental BRW
    Accessories, Implant, Dental, Endosseous NDP
    Aligner, Sequential NXC
    Resin, Denture, Relining, Repairing, Rebasing EBI

    Proprietary Names

    Tera Tainer (Model : TA-83) TERA HARZ II TERA HARZ TeraFlex Guard (Model : TeraFlex) Tera Harz Guard (Model : TE-151) TERA HARZ SG TERA HARZ CLEAR (TC-85DAC, TR-07, TA-28) TERA HARZ DENTURE Tera Harz Hard Denture

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device