BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    DENTATUS AB

    Reg #: 8030870 · FEI: 3006944200 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    51
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    DENTATUS AB
    Registration Number
    8030870
    FEI Number
    3006944200
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Finspangsgatan 42
    City
    SPANGA Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K040143

    Owner / Operator

    Firm Name
    DENTATUS AB
    Operator Number
    8030870
    Address
    FINSPANGSGATAN 42, ---
    City
    SPANGA
    State
    SE-NOTA
    Postal Code
    SE-163 53
    Country
    SE
    Correspondent
    Mikael - Skoglund

    US Agent

    Business Name
    Dentatus USA Ltd
    Contact Name
    Thomas Murphy
    Address
    50 Broadway ste #10
    City
    Hawthorne
    State
    NY
    ZIP
    10532
    Country
    US
    Email
    [email protected]
    Phone
    212 4811010

    Products

    Device Name Product Code
    Point, Abrasive EHL
    Instrument, Diamond, Dental DZP
    Facebow KCR
    Handle, Instrument, Dental EJB
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Bur, Dental EJL
    Post, Root Canal ELR
    Retainer, Matrix JEP
    Articulators EJP
    Drill, Dental, Intraoral DZA
    Accessories, Retractor, Dental EIF
    Instruments, Dental Hand DZN
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Implant, Endosseous, Root-Form DZE
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Per-io-Tor Tips EVA Tips LTA Lamineer Tips FD Dentatus Diamond Instruments AEE Facebow AEB Facebow AEV Facebow AEC Facebow AEP Facebow AEK Facebow Profin-By-Hand Profin/EVA Profinet CePo Pilot drills Surtex Classic Aztec Twin Luscent Luscent-R Classic Sterile Surtex Luscent MEC ARH ARD ARL/P Maaxloc ARL RUG RUH RSA RSG RSC RUB RUF RUA RSI RSB RSH RUD DENTATUS Dentatus Matrix Bands Forms-to-Fit Luminex MTI Monorail ANEW Atlas TufLink Anew acessories MTI Monorail acessories Atlas acessories

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device