BEUDAMED
    FDA Registration Active 🇫🇷 France

    DENTAL HI TEC

    Reg #: 3008579121 · FEI: 3008579121 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    DENTAL HI TEC
    Registration Number
    3008579121
    FEI Number
    3008579121
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rue de Champs Blanc
    City
    Mazieres en Mauges Maine-et-Loire
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K243427

    Owner / Operator

    Firm Name
    Dental Hi Tec
    Operator Number
    10059566
    Address
    Rue de Champs Blanc
    City
    Mazieres en Mauges
    State
    Maine-et-Loire
    Postal Code
    49280
    Country
    FR
    Correspondent
    Olivier Villette

    US Agent

    Business Name
    Dentalhitec Americas
    Contact Name
    Mohammad Sargazi
    Address
    3535 W. 12th Street, 2nd Floor
    City
    Houston
    State
    TX
    ZIP
    77008
    Country
    US
    Email
    [email protected]
    Phone
    346 5846363

    Products

    Device Name Product Code
    Injector, Jet, Mechanical-Powered EGM
    Syringe, Cartridge EJI
    Needle, Dental DZM

    Proprietary Names

    QuickSleeper5 Effitec needles Soan SleeperOne5

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device