BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTSPLY LLC

    Reg #: 2424472 · FEI: 3002088145 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    DENTSPLY LLC
    Registration Number
    2424472
    FEI Number
    3002088145
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1301 SMILE WAY
    City
    York
    State
    PA
    ZIP
    17404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072134

    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
    System, X-Ray, Extraoral Source, Digital MUH
    Unit, X-Ray, Extraoral With Timer EHD
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198