BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SPIDENT CO., LTD.

    Reg #: 3006113314 · FEI: 3006113314 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    38
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    SPIDENT CO., LTD.
    Registration Number
    3006113314
    FEI Number
    3006113314
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    312, 151B-6L NAMDONGGONGDAN
    City
    INCHEON Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K231523

    Owner / Operator

    Firm Name
    SPIDENT CO., LTD.
    Operator Number
    9089446
    Address
    312, 151B-6L NAMDONGGONGDAN, --
    City
    INCHEON
    State
    KR-NOTA
    Postal Code
    405-821
    Country
    KR

    US Agent

    Business Name
    Withus Group Inc
    Contact Name
    April Lee
    Address
    106 Superior
    City
    Irvine
    State
    CA
    ZIP
    92620
    Country
    US
    Email
    [email protected]
    Phone
    909 2749971

    Products

    Device Name Product Code
    Preparer, Root Canal Endodontic EKQ
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Dam, Rubber EIE
    Mask, Surgical FXX
    Cement, Dental EMA
    Resin, Root Canal Filling KIF
    Activator, Ultraviolet, For Polymerization EBZ
    Tray, Impression, Preformed EHY
    Liner, Cavity, Calcium Hydroxide EJK
    Patient Examination Glove FMC
    Point, Paper, Endodontic EKN
    Material, Impression Tray, Resin EBH
    Accessories, Retractor, Dental EIF
    Needle, Dental DZM
    Gutta-Percha EKM
    Material, Impression ELW
    Crown And Bridge, Temporary, Resin EBG

    Proprietary Names

    SoftPrep EsCom250 Temp.ro, Temp.ro Flow K-Bond Universal Bonding Agent FineDam BLooming Masks EsTemp Implant EsFlow PLUS VioSeal Core It Dual FOCUS EsTemp NE EsBond Spident Bite Tray EsCem Resin Cement Base It EsCem RMGI Resin-Modified Glass Ionomer Cement EsFlow Seal it Magnificent Flowable Composite BLooming Gloves PAPAER POINTS Absorbent Paper Accessory Points Paper Point Block-Out Resin FineEtch EsCom 100 Retraction Cord NOP Dental Needles GUTTA PERCHA POINTS Gutta Percha I-Sil Vinyl Poly Siloxane Temporary Crown & Bridge Material EsTemp C&B

    Establishment Types

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