BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SHERPA KOREA

    Reg #: 3008922120 · FEI: 3008922120 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    110
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    SHERPA KOREA
    Registration Number
    3008922120
    FEI Number
    3008922120
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    438-1, Hasinbeonyeong-ro
    City
    Saha-gu Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K010012

    Owner / Operator

    Firm Name
    Sherpa
    Operator Number
    10035326
    Address
    #902, 468, Gangseo-ro
    City
    Gangseo-gu
    State
    Seoul
    Postal Code
    07573
    Country
    KR
    Correspondent
    HyeongJoo Moon

    Products

    Device Name Product Code
    Crown And Bridge, Temporary, Resin EBG
    Reliner, Denture, Over The Counter EBP
    Material, Impression ELW
    Tray, Impression, Preformed EHY
    Syringe, Restorative And Impression Material EID
    Knife, Margin Finishing, Operative EJZ

    Proprietary Names

    Deli-Temp SP Reline Soft e&e Denture Soft Reline Kit e&e Putty Fast Set DIOSIL Heavy Body DIOSIL Bite Delikit Medium Body Precisil Bite Registration Hard Precisil Mask Precisil Light Body FS Precisil Secret Vaccusil Bite Registration Vaccusil Heavy Body FS Deli Mask Delikit Bite Registration Precisil Heavy Body FS Delikit Heavy Body FS Precisil Light Body Precisil Regular Body FS Precisil Tornado Monophase Delikit Tornado Heavy Body Precisil Putty FS Vaccusil Light Body Delikit Regular Body FS Precisil Plant Light Body Deli Plant Light Body Precisil Heavy Body Delikit Extra Light Body Precisil Heavy Body Hybrid set Deli plant Light Body FS Imflex Monophase Mojo Complete STRONGBITE PLUS REGULAR BODY Deli Plant Heavy Body FS Precisil Extra Light Body Imflex Light Body Fast Delikit Heavy Body Precisil Jumbo Monophase Precisil Regular Body Biggg Densurefit Delikit Putty RS Precisil Bite Registration Trimming Precisil Plant Heavy Body Delikit Light Body FS Precisil Bite Registration Fast Precisil Light Body Trend Delikit Putty FS Precisil Bite Registration Normal Precisil Medium Body Delikit Light Body Precisil Bite Registration Imflex Heavy Body Delikit Regular Body Precisil Plant Heavy Body FS Delikit Jumbo Monophase Precisil Big Precisil Putty RS Vaccusil Light Body FS Deli Plant Heavy Body Precisil Denture Deli-Big Precisil Heavy Body Biggg Delikit Tornado Monophase Vaccusil Heavy Body FS 120ml Precisil Tornado Heavy Body Imflex Light Body Precisil Light Body Hybrid set Precisil Soft Imflex Putty Imflex Heavy Body Fast Precisil Regular Body STRONGBITE PLUS PUTTY Deli-Border Vaccusil Heavy Body Delikit Secret Precisil Premium Light Body Vaccusil Heavy Body RS 120ml Deli Denture Jackpot Light Body Imflex Putty Fast Imflex Bite STRONGBITE PLUS BITE REGISTRATION Bio Cell Light Body Bio Cell Heavy Body Jackpot Light Body Fast Bio Cell Bite Deli-Bite Clear Precisil Jumbo Big STRONGBITE PLUS LIGHT BODY Fast Set STRONGBITE PLUS HEAVY BODY Fast Set Monophase Simplify Precisil Bite Trimming Delikit Premium Putty Jackpot Big Light Body fast Delikit Premium Light Body Jackpot Bite Neo Fit Light Body 3 Delikit 200 Heavy Body e&e putty eco e and e putty Neo Fit Heavy Body Neo Fit Light Body e&e Putty Eco Regular Set DIOSIL Putty DIOSIL Light body e&e Bite Registration Excel Impression Tray Green Flat Tip 6.5 mm Yellow Mixing Tip 4.5 mm GP Cutter and Trimmer

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device