BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Durr Optronik GmbH & Co. KG

    Reg #: 3001052305 · FEI: 3001052305 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    33
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    Durr Optronik GmbH & Co. KG
    Registration Number
    3001052305
    FEI Number
    3001052305
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gultlinger Str. 14
    City
    Gechingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K170733

    Owner / Operator

    Firm Name
    DURR DENTAL SE
    Operator Number
    10047925
    Address
    Hopfigheimer Str. 17
    City
    Bietigheim-Bissingen
    State
    Baden-Wurttemberg
    Postal Code
    74321
    Country
    DE
    Correspondent
    Oliver Lange

    US Agent

    Business Name
    Air Techniques, Inc.
    Contact Name
    Joseph Latkowski
    Address
    1295 Walt Whitman Rd
    City
    Melville
    State
    NY
    ZIP
    11747
    Country
    US
    Email
    [email protected]
    Phone
    516 2145574

    Products

    Device Name Product Code
    Unit, Operative Dental, Accessories NRD
    System, X-Ray, Extraoral Source, Digital MUH
    Holder, Film, X-Ray EGZ
    Dental Barriers And Sleeves PEM
    X-Ray, Tomography, Computed, Dental OAS
    Film, Radiographic IWZ
    Laser, Fluorescence Caries Detection NBL
    System, Image Processing, Radiological LLZ
    Caries Detector, Laser Light, Transmission NTK

    Proprietary Names

    CamX Elara CamX Triton HD Cam Mojave Mobile Mojave Mobile with Amalgam Separator VS 250 S (VacStar Viper) CamX Triton HD Handpiece ScanX Classic View ScanX Swift View ScanX Intraoral View VistaPosition Endo VistaPosition Anterior VistaPosition Bitewing VistaPosition Posterior CamX Triton HD Camera Sheath ProVecta 3D Prime Ceph ProVecta 3D Prime Phosphor Storage Plate IDX S1 Phosphor Storage Plate IDX S2 Phosphor Storage Plate IDX S0 Phosphor Storage Plate IDX S3 Phosphor Storage Plate IDX S4 CamX Triton HD Spectra CamX Spectra ScanX Swift 2 ScanX Swift View 2 VisionX ProVecta 3D Prime with VisionX SensorX Size #1 SensorX Size #2 ScanX Barrier Envelope, 100 Pcs, Size 0 (73248-0) ScanX Barrier Envelope, 300 Pcs, Size 2 (73248-2) ScanX Edge CamX Triton HD Proxi

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device