BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    DHEF INC.

    Reg #: 8043962 · FEI: 3002948158 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    21

    Registration Details

    Registration Name
    DHEF INC.
    Registration Number
    8043962
    FEI Number
    3002948158
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15F., NO. 104 & 106, HSIN TAI WU RD., SEC. 1, HSI CHIH DIST.
    City
    NEW TAIPEI CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K955759

    Owner / Operator

    Firm Name
    DHEF INC.
    Operator Number
    9004856
    Address
    128 TUN HWA SOUTH RD.,, 7TH FL.-2, SEC. 2
    City
    TAIPEI
    State
    TW-NOTA
    Postal Code
    --
    Country
    TW

    Products

    Device Name Product Code
    Activator, Ultraviolet, For Polymerization EBZ
    Film, Radiographic IWZ
    Scaler, Ultrasonic ELC
    Mirror, Mouth EAX
    Camera, Surgical And Accessories KQM
    Bur, Dental EJL
    Illuminator, Radiographic-Film IXC
    Heat Source For Bleaching Teeth EEG
    Light, Fiber Optic, Dental EAY
    Light, Operating, Dental EAZ
    Unit, Operative Dental, Accessories NRD
    Drill, Dental, Intraoral DZA
    Tray, Impression, Preformed EHY
    Cup, Prophylaxis EHK
    Unit, X-Ray, Extraoral With Timer EHD
    Aligner, Beam, X-Ray EHA
    Holder, Film, X-Ray EGZ
    Instrument, Hand, Calculus Removal ELA
    File, Pulp Canal, Endodontic EKS
    Handpiece, Direct Drive, Ac-Powered EKX
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    ULTRASONIC SCALER POLYMAS Mouth Mirror & Accessories, Mirror Defogger, Dental Hand Instrument DENTAL BUR FIBER OPTIC LIGHT DRILL INTRAORAL PROPHYLAXIS CUP ENDO FILE

    Establishment Types

    Manufacture Medical Device