BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ProVecta 3D Prime Ceph

    Reg #: 3015509619 · FEI: 3015509619 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    DURR DENTAL SE
    Registration Number
    3015509619
    FEI Number
    3015509619
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hopfigheimer Str. 17
    City
    Bietigheim-Bissingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K232487

    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
    System, Image Processing, Radiological LLZ
    X-Ray, Tomography, Computed, Dental OAS

    Proprietary Names

    ProVecta 3D Prime Ceph ProVecta 3D Prime

    Establishment Types

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