BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DURR DENTAL SE

    Reg #: 3015509619 · FEI: 3015509619 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    41
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    DURR DENTAL SE
    Registration Number
    3015509619
    FEI Number
    3015509619
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hopfigheimer Str. 17
    City
    Bietigheim-Bissingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K181432

    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
    Holder, Film, X-Ray EGZ
    X-Ray, Tomography, Computed, Dental OAS
    System, Image Processing, Radiological LLZ
    Film, Radiographic IWZ
    System, X-Ray, Extraoral Source, Digital MUH
    Laser, Fluorescence Caries Detection NBL
    Automated Radiological Image Processing Software QIH
    Unit, Operative Dental, Accessories NRD
    Evacuator, Oral Cavity EHZ
    Caries Detector, Laser Light, Transmission NTK

    Proprietary Names

    VistaPosition Endo VistaPosition Anterior VistaPosition Bitewing VistaPosition Posterior ProVecta 3D Prime with VisionX 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 ScanX Classic View ScanX Swift View ScanX Intraoral View CamX Triton HD Spectra CamX Spectra VisionX 4 VistaSoft 4 ScanX Swift 2 ScanX Swift View 2 CamX Elara CamX Triton HD Cam Mojave Mobile Mojave Mobile with Amalgam Separator VS 250 S (VacStar Viper) CamX Triton HD Handpiece Universal Cannula Protect, d=16 mm, grey Prophylaxis Cannula, d=16 mm, grey Y-Adapter Set Adapter 16-11 Adapter 11 to 16mm for HVE Air Protect XL, XL Plus Universal Cannula, d=16 mm, grey HVE Air Protect XL, gray HVE Y-Adapter (11 to 16mm for HVE Air Protect XL Plus) HVE Air Protect XL Plus, gray VisionX ProVecta 3D Prime Ceph ProVecta 3D Prime ScanX Edge CamX Triton HD Proxi SensorX Size #1 SensorX Size #2

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device