BEUDAMED
    FDA Registration Active 🇵🇹 Portugal

    CA PRIMA 1:121

    Reg #: 3013576763 · FEI: 3013576763 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    190
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIEN-AIR PORTUGAL, UNIPESSOAL LDA
    Registration Number
    3013576763
    FEI Number
    3013576763
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rua Ponte da Pedra, N 240, Centro Empresarial Aaa
    City
    Maia Porto
    Country
    PT

    Regulatory Submissions

    510(k) Number
    K983183

    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

    CA PRIMA 1:121 CA PRIMA 1:1 HOSE TUR BORALINA TUR BORA TUR PRESTIGE LUBRIMED TUR PRESTILINA ADAPTER PM CA EVO SPRAYNET CA TUR BLACK PEARL CABLE TUR GYRO AQUACARE LUBRIFLUID TUR TORNADO TUR EOLIA CA 1:1 L CA 20:1 COUPLING SOCKET B B-MX2 COUPLING UNIFIX 4H L WATER ADJ HOSE MC2 GREY CA 15:1 PROPHY PM 1:2 TUR TORNADO S MOT ISOLITE LI TUR BORA LK HOSE B-4VX GREY CA 30:1 EXT SPRAY WELDED TUR TORNADO X CA ENDO HOSE 4VR400 GREY MIDWEST PM 1:1 EXT SPRAY LARES HOSE MX2 400 PLANMECA CA 1:5 L EVO15 MICRO-SERIES TUR PRESTIGE L BLACKLINE LED PM PROLAB HOSE MX2 400 SURF 6 CA 20:1 L HOSE MC E BLACK HOSE MCX GREY 20.2x40 HOSE 4VR400 SURF6 ADEC HOSE MCX GREY CA 1:1 MOT MC3 LK COUPLING MULTIFLEX® 4H L BUR GUARD HP 1:2 (100 PCES) CA NOVA 1:5L MS HOSE 6 HOLE L GREY MIDWEST HOSE 4VX GREY MOT MC2 GT AV CA 20:1 L KM HOSE B-MX2 GREY HOSE 4VLM10 BLACK HOSE ISOLITE/MC2 SWIVEL WHITE HOSE MX2 400 GREY 20.2x40 CA 1:1 L MICRO-SERIES LARES CA 1:1 EXT SPRAY WELDED HOSE ISOLITE/MC2 COILED BLACK HOSE MCX GREY 400 20.2x40 HOSE MCX GREY ADEC CA 20:1 L KM MICRO-SERIES UPGRADE KIT BUR GUARD HP 1:2 MOT MC3 IR COUPLING UNIFIX® 4VL Midwest HOSE SCALER POWERCARE MOT AQUILON830 IR NC HOSE 4 HOLE L SURF6 MIDWEST COUPLING UNIFIX 4H TUR TORNADO S LED HOSE B-4VR 400 GREY L 1700 COUPLING UNIFIX 3H HOSE 4VLM11 SURF6 ADEC HOSE T LE WHITE PRESTIGE - 5 HOLE W/O COUPLER TUR PRESTIGE LK TUR TORNADO X LK HOSE 4VLM11 GREY CA NOVA 1:1L MS CA NOVA 1:5L CA ENDO + ACTIVATION CODE SET STUDENTS BAUSA 5 CA 1:1 L LARES CA 1:5 L LARES COUPLING EOLIA B 4H TUR BLACK PEARL ECO 3H HOSE 4VR400 GREY HOSE MCX GREY 2.2m MOT MC2 IR MOT AQUILON830 SR COUPLING SOCKET B 4B-VX SET STUDENTS BAUSA 7 MOT MC2 SR TUR PRESTIGE L LED TUR BORA L TUR TORNADO X LED CA 1:1 EXT SPRAY CA 1:5 L PM 1:1 HOSE ISOLITE/MC2 SWIVEL GREY MOT MCX LED MOT MX-I LED NB MOT MC2 TUR BORA L BLACKLINE TUR TORNADO LK HOSE 5 HOLE L GREY MIDWEST COUPL MULTIFLEX® 4HL WATER ADJ TUR BLACK PEARL 4H B CARE HOSE ISOLITE/MC2 WHITE MOT MX-i LED CA 1:2.5 L MS MOT MX CHIROPRO HOSE B-4VR400 GREY CA 1:5 L EVO15 CA 20:1 L MICRO-SERIES PM 10:1 PROPHY HOSE MX2 400 GREY MOT MC2 40 GT IR TUR PRESTIGE LK BLACKLINE TUR TORNADO S LK CA 10:1 L PM 1:1 MICRO-SERIES CA 1:1 L EVO15 CA NOVA 1:1L MOT MC3 (LED) HOSE MX2 GREY HOSE MC2 LE T GREY HOSE 4 HOLE L M 10 GREY B CA 1:5 L MICRO-SERIES LARES TUR TORNADO LED TUR BORA LK BLACKLINE HOSE B-MCX GREY HOSE 4VX SURF6 ADEC CA 1:5 L MICRO-SERIES CA 30:1 EXT SPRAY COUPLING HOSE ISOLITE WATER ADJ GREY COUPLING UNIFIX 4H L MOT ISOLITE LK HOSE ISOLITE/MC2 BLACK CA 1:1 L MICRO-SERIES CA 1:1 L EVO15 MICRO-SERIES HOSE ISOLITE/MC2 SWIVEL BLACK CA 10:1 PM 1:1 EXT SPRAY HOSE 4VLM11 BLACK TUR BORA L LED HOSE 4 HOLE L BLACK MIDWEST CA 1:5 COUPLING SOCKET B HOSE 4VLM GREY MOT ISOLITE (LED) HOSE MC MEDICAMAT COUPLING UNIFIX 4H US TUR PRESTIGE L SET STUDENTS BAUSA 6 MOT MX SET STUDENTS BAUSA 4 MOT AQUILON MOT MC3 MOT MX-i MOT MCX MOT ISOLITE MOT MX2 MOT BASCH TU Bora 2 LK TU Bora 2 LED SET STUDENTS BAUSA 13 SET STUDENTS BAUSA 14 I-SURGE LED PM CA 1:5L NOVA MS PM CA 1:1 L S-NXC MC MX2 CA 1:2.5 L SET STUDENTS BAUSA 8 CA PRIMA 1:1 L PM CA 20:1 L RO 104936 XPU MMOTOR NO LIGHT LIGHT MOTOR XPU MMOTOR CABLE CABLE I-SURGE LED PM HP 1:1 sp. ext. CA PRIMA 1:1 L MS TY MX2 400° calotte 20.2x40 XPU MMOTOR LIGHT HOSE LIGHT MOTOR PM PM 1:1 RO sp. ext. 104936

    Establishment Types

    Manufacture Medical Device