BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Acteon® Newtron LED Piezoelectric Scaler

    Reg #: 3029780 · FEI: 1000523896 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DCI International, LLC
    Registration Number
    3029780
    FEI Number
    1000523896
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    705 S SPRINGBROOK RD., Bldg C
    City
    NEWBERG
    State
    OR
    ZIP
    97132
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132267

    Owner / Operator

    Firm Name
    DCI International LLC
    Operator Number
    9099996
    Address
    705 S Springbrook Rd, Bldg. C
    City
    Newberg
    State
    OR
    Postal Code
    97132
    Country
    US
    Correspondent
    Dana Shusterman

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC

    Proprietary Names

    Acteon® Newtron LED Piezoelectric Scaler

    Establishment Types

    Repack or Relabel Medical Device