BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    LUBRICARE MAINTENANCE SYSTEM

    Reg #: 9614446 · FEI: 3002762033 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIEN-AIR DENTAL SA
    Registration Number
    9614446
    FEI Number
    3002762033
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LANGGASSE 60
    City
    Biel/Bienne Bern
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K070074

    Owner / Operator

    Firm Name
    BIEN-AIR DENTAL SA
    Operator Number
    9034059
    Address
    Langgasse 60, --
    City
    BIENNE
    State
    Bern
    Postal Code
    2504
    Country
    CH
    Correspondent
    Carine - Beriet

    US Agent

    Business Name
    BIEN AIR USA, INC.
    Contact Name
    ARTHUR MATEEN
    Address
    5 CORPORATE PARK, SUITE 160
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US
    Email
    [email protected]
    Phone
    949 4776050

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    LUBRICARE MAINTENANCE SYSTEM

    Establishment Types

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