BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Star 500 Elite Handpiece, Lubricated, Fiber Optic

    Reg #: 2520265 · FEI: 2520265 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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
    K192412

    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, Air-Powered, Dental EFB

    Proprietary Names

    Star 500 Elite Handpiece, Lubricated, Fiber Optic Star 500 Elite Handpiece, Lubricated non-Fiber Optic Star 500 Swivel, non-Fiber Optic Star 500 Elite Handpiece, LubeFree, non-Fiber Optic Star 400 Flex Handpiece, Lubricated, Fiber Optic Star 400 Flex Handpiece, LubeFree, Fiber Optic Star 500 Swlvel, Fiber Optic Star 500 Elite Handpiece, LubeFree, Fiber Optic Star 400 Flex Handpiece, LubeFree, non-Fiber Optic Star 400 Flex Handpiece, Lubricated, non-Fiber Optic

    Establishment Types

    Manufacture Medical Device