BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Self-Cure Activator

    Reg #: 2515379 · FEI: 2515379 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DENTSPLY LLC
    Registration Number
    2515379
    FEI Number
    2515379
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    38 WEST CLARKE AVENUE
    City
    MILFORD
    State
    DE
    ZIP
    19963
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050386

    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
    Agent, Tooth Bonding, Resin KLE

    Proprietary Names

    Self-Cure Activator Prine & Bond NT DC Nano-Tech

    Establishment Types

    Manufacture Medical Device