BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTSPLY NORTH AMERICA LLC

    Reg #: 3006186796 · FEI: 3006186796 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DENTSPLY NORTH AMERICA LLC
    Registration Number
    3006186796
    FEI Number
    3006186796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1800 Cloister Drive
    City
    Lancaster
    State
    PA
    ZIP
    17601
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191865

    Owner / Operator

    Firm Name
    DENTSPLY SIRONA INC
    Operator Number
    2511302
    Address
    221 WEST PHILADELPHIA ST., SUITE 60W
    City
    York
    State
    PA
    Postal Code
    17401
    Country
    US

    Products

    Device Name Product Code
    Caries Detector, Laser Light, Transmission NTK
    Activator, Ultraviolet, For Polymerization EBZ

    Establishment Types

    Repack or Relabel Medical Device