BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    SET CHIROPRO L US PM HP 1:2

    Reg #: 3003268570 · FEI: 3003268570 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    66
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Bien-Air Dental SA
    Registration Number
    3003268570
    FEI Number
    3003268570
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rue de l'Ouest 2b
    City
    Le Noirmont Jura
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K092214

    Owner / Operator

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

    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
    Controller, Foot, Handpiece And Cord EBW

    Proprietary Names

    SET CHIROPRO L US PM HP 1:2 CONSOLE CHIROPRO PLUS 3RD GEN SET CHIROPRO L SET CHIROPRO L US SET CHIROPRO L PREMIUM SET CHIROPRO L PREMIUM CA 20:1 L SET OSSEOCARE US CONSOLE CHIROPRO CONSOLE CHIROPRO 3RD GEN CONSOLE CHIROPRO L PREMIUM US CONSOLE CHIROPRO L PREMIUM SET iCHIROPRO KM SET iCHIROPRO SURGERY US PM HP 1:2 MOT MXi-LED SET CHIROPRO+ CA 20:1 L CONSOLE OSSEOCARE US SET iCHIROPRO SURGERY US CONSOLE CHIROPRO L US CA 20:1 L SET CHIROPRO L + CA 20:1 L SET CHIROPRO CA 20:1 L SET iCHIROPRO + CA 20:1 L MS SET iCHIROPRO CA 20:1 L MS KM SET OSSEOCARE CA 20:1 L MS NB CA 20:1 l MICRO SERIES SET CHIROPRO SET CHIROPRO L US CA 20:1 L SET OSSEOCARE US CA 20:1 L MS SET CHIROPRO L CA 20:1 SET PROIMPLANT SET CHIROPRO + CA 20:1 CA 20:1 SET CHIROPRO 3RD GEN CA 20:1L AQUACARE CABLE MX-i LED 3RD GEN FOOTCTRL CHIROPRO980 MOT MX-i LED 3RD GEN SET CHIROPRO 3RD GEN Chiropro 980 4 Buttons Foot Control CABLE MX LED 3M CONSOLE PROIMPLANT SET CHIROPRO 3RD GEN KM CONSOLE PROIMPLANT 3RD GEN SET OMS SET PROIMPLANT 3RD GEN CA 20:1 L CONSOLE OMS FOOTCTRL SET CHIROPRO 3RD GEN KM CA SET PROIMPLANT 3RD GEN CA 20:1 CONSOLE iCHIROPRO MOT MX-LED SET OSSEOCARE PRO CABLE MX-LED CONSOLE CHIROPRO L MOT MX-i LED SET iCHIROPRO CONSOLE OSSEOCARE PRO CA 20:1 L MICRO-SERIES SET CHIROPRO L US PREMIUM SET iCHIROPRO SURGERY CONSOLE OSSEOCARE CONSOLE iCHIROPRO SURGERY SET OSSEOCARE CABLE MX-i LED SET CHIROPRO+ 3RD GEN CA 20:1 L MOT MX-i

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)