BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iStar Cordless Prophy Handpiece

    Reg #: 2520265 · FEI: 2520265 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DENTALEZ, INC., STARDENTAL DIVISION
    Registration Number
    2520265
    FEI Number
    2520265
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1816 Colonial Village Ln
    City
    Lancaster
    State
    PA
    ZIP
    17601
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131578

    Owner / Operator

    Firm Name
    DENTALEZ, INC.
    Operator Number
    2513147
    Address
    301 Lindenwood Drive, Suite 100
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    iStar Cordless Prophy Handpiece

    Establishment Types

    Repack or Relabel Medical Device