BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BOARD DMX2 PLUS

    Reg #: 9614446 · FEI: 3002762033 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    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
    K042759

    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
    Unit, Operative Dental EIA

    Proprietary Names

    BOARD DMX2 PLUS CONSOLE iOPTIMA CONSOLE OPTIMA MX2-E Board DMX3 CONSOLE OPTIMA MCX CONSOLE OPTIMA INT CONSOLE iOPTIMA INT 1x MX2 KIT OPTIMA MX2 INT BOARD DMX2 PRO AP OPTIMA MCX SET iOPTIMA INT MX2 MX-i LIGHT BOARD DMX3 FULL OPEN SET iOPTIMA INT 2x MX2 LIGHT BOARD iOPTIMA CONSOLE OPTIMA MX2 INT DMX3 CL CONSOLE OPTIMA MX2 WHITE EDU SET OPTIMA MX2 INT SET OPTIMA INT KIT OPTIMA INT SET iOPTIMA INT 1x MX2 FULL BOARD DMX S BOARD MPPE021 FO BOARD DMX3 iOPTIMA INT BOX SET OPTIMA MX2 PRO INT OPTIMA MCX INT DMCX 1 MOTOR BOARD DMX BELMONT CONSOLE iOPTIMA INT 2x MX2 SET iOPTIMA INT MX2 MX-i FULL BOARD FO890 BOARD iCHIROPRO SET iOPTIMA INT 2x MX2 FULL BOARD DMX2 OPTIMA MX2 INT DMX3 2 MOTORS CONSOLE iOPTIMA INT MX2 MX-i BOARD DMX DIGIPAD OPTIMA MCX INT DMX3 1 MOTOR OPTIMA MX2 INT PRO 2 MOTORS SET iOPTIMA INT 1x MX2 LIGHT OPTIMA MX2 INT DMX3 1 MOTOR CONSOLE OPTIMA MX2 INT PRO CL BOARD DMX PRO BOARD DMX BOARD DMCX CONSOLE OPTIMA MX2 INT BOARD DMX-i CONSOLE OPTIMA MX INT BOARD DMX BASIC CONSOLE OPTIMA MX NGO motor driver IDUP Board SET OPTIMA MX2 EDUCATIONAL 6

    Establishment Types

    Manufacture Medical Device