BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Dental Direkt GmbH

    Reg #: 3008347275 · FEI: 3008347275 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    23
    Establishment Types
    4
    Classifications
    7

    Registration Details

    Registration Name
    Dental Direkt GmbH
    Registration Number
    3008347275
    FEI Number
    3008347275
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Industriezentrum 106-108
    City
    Spenge North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K193588

    Owner / Operator

    Firm Name
    Dental Direkt GmbH
    Operator Number
    10032224
    Address
    Industriezentrum 106-108
    City
    Spenge
    State
    North Rhine-Westphalia
    Postal Code
    32139
    Country
    DE

    US Agent

    Business Name
    MEDAGENT, Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Powder, Porcelain EIH
    Crown And Bridge, Temporary, Resin EBG
    Accessories, Implant, Dental, Endosseous NDP
    Abutment, Implant, Dental, Endosseous NHA
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Mouthguard, Prescription MQC
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    DD contrast Nacera Pearl Shaded 16+2 DD poly Y ML DD cube ONE DD cubeX² ML DD Pro Shade Z DD Basic Shade DD Art Elements DD Pro Shade C DD cubeX² DD cube ONE ML DD Scanbody 2 DD Ti-Base 2CUT DD Ti-Base 2CUT noLock DD Prefab DD base P HI DD Bio Splint P HI DD Bio ZX² color DD Bio ZX² DD Bio ZW iso i700 DD cubeY HL Nacera Pearl Natural

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)