BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SAESHIN PRECISION CO., LTD.

    Reg #: 3007958831 · FEI: 3007958831 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    69
    Establishment Types
    1
    Classifications
    15

    Registration Details

    Registration Name
    SAESHIN PRECISION CO., LTD.
    Registration Number
    3007958831
    FEI Number
    3007958831
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun
    City
    Daegu
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K100192

    Owner / Operator

    Firm Name
    Saeshin Precision Co., Ltd.
    Operator Number
    10030579
    Address
    52, Secheon-ro 1-gil, Dasa-eup,, Dalseong-gun
    City
    Daegu
    State
    KR-27
    Postal Code
    42921
    Country
    KR
    Correspondent
    Jung Ho LEE

    US Agent

    Business Name
    Saeshin America, Inc
    Contact Name
    Youngsun Lee
    Address
    32 Mauchly, Unit C
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 8256925

    Products

    Device Name Product Code
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Handpiece, Air-Powered, Dental EFB
    Motor, Drill, Electric HBC
    Unit, Oral Irrigation EFS
    Controller, Foot, Handpiece And Cord EBW
    Drill, Bone, Powered DZI
    Handpiece, Direct Drive, Ac-Powered EKX
    Handpiece, Water-Powered EKY
    Handle, Instrument, Dental EJB
    Handpiece, Belt And/Or Gear Driven, Dental EFA
    Blade, Saw, Surgical, Cardiovascular DWH
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Motor, Surgical Instrument, Ac-Powered GEY
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Saw, Powered, And Accessories HAB

    Proprietary Names

    Strong Dental Handpieces MEARA; MEAHP TRAUS high-speed air turbine Handpieces SSG30 DB-003 DB-001 DB-005 ACL(B)-61I, ACL(B)-62I, ACL(B)-63I, ACL(B)-65I, ACL(B)-04C Maxima Elite i Maxima Elite iL AHP-85-SS BIODENT SIP10 TRAUS SIP 10 Traus SIP20 DENTIS DIP20 STRONG IMPLANT HANDPIECES SSG10 Traus SUS20 PIEZOART RF503NU8 WF20R065KT SD507A RD703NU CF22R075KT RF303NU8 TA114C CF20R65KT TA115C RF703NU8 RD303NU SB300A TA110B CF31R070KT CF30R100KT TRAUS SSG10 Blade System RD503NU WF29R065KT AF30R065KT TA113C X-CUBE OsseoFuse Harpoon 1 TRAUS CRB46LN TRAUS CRB46NN TRAUS SSG40 ATR10YJ ATS10YS TRAUS SSG20 ATS10YR ATK11YN ATK10YN ATK12YN ATD10YA ATD10YH TD-AUTO ATR10YA ATD10YJ ATR10YH E-cube EM type Motor set B350D motor set FUE straight handpiece Strong AT-II B170 motor set E-CUBE TRAUS SSG30 TRAUS SSG10 SIP20FT Motor Handpiece and Control Unit (SDI10) SDI10 Traus Ultrasonic tips

    Establishment Types

    Manufacture Medical Device