BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
US Last updated 24 May 2026
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- Devices
- 67
- Registries
- GUDIDEUDAMEDFDA
- FDA recalls
- 0
Catalogue
Pm 1:1 Ext Spray 1600052-001USA Ref 1600052-001USA
Ca 1:5 L 1600386-001USA Ref 1600386-001USA
Pm 1:2 1600436-001USA Ref 1600436-001USA
Mot MX2 1600677-001USA Ref 1600677-001USA
Ca 20:1 L Micro-Series 1600692-001USA Ref 1600692-001USA
MOT MX-i LED 1600755-001USA Ref 1600755-001USA
Ca 8:1 1600911-001 Ref 1600911-001
Ca Nova 1:1L Ms 1601136-001USA Ref 1601136-001USA
Ca Nova 1:5L Ms 1601138-001USA Ref 1601138-001USA
Hose MCX OSSTEM 1601264-001 Ref 1601264-001
Hose MX2 400 GREY_102646 1601249-001 Ref 1601249-001
Hose 4VLM11 SURF6 Adec 1043807-001 Ref 1043807-001
Hose 4VR400 SURF6 Adec 1600423-001 Ref 1600423-001
Hose Mc Medicamat 1600272-001 Ref 1600272-001
Tur Prestige 1600379-001 Ref 1600379-001
Hose T LE White 1600131-001 Ref 1600131-001
Mot MC2 GT AV 1600075-001 Ref 1600075-001
TY MX2 400° calotte Ø20.2x40 1600809-0 Ref 1600809-0
Ca Endo 1600955-001 Ref 1600955-001
Tur Bora L 1600382-001 Ref 1600382-001
Coupling Unifix 4H L Water Adj 1600086-001 Ref 1600086-001
HOSE B-4VX GREY new 1600537-001 Ref 1600537-001
Hose Isolite/MC2 Swivel Black 1600299-001 Ref 1600299-001
HOSE 4VX GREY (16x27) 1600536-001 Ref 1600536-001
Hose MX2 Grey 1600678-001 Ref 1600678-001
Hose Scaler Powercare 1600675-001 Ref 1600675-001
Hose 4VX Grey 1600387-001 Ref 1600387-001
Cable MX LED 1600606-001 Ref 1600606-001
Hose MCX Grey ADEC 1600820-001 Ref 1600820-001
Coupling Multiflex 4H L 1600902-001 Ref 1600902-001
Hose Isolite/MC2 Swivel White 1600316-001 Ref 1600316-001
Prestige - 5 Hole W/O Coupler 1600046-001 Ref 1600046-001
Tur Bora L LED 1600638-001 Ref 1600638-001
Hose MC E Black 1600124-001 Ref 1600124-001
Coupl Multiflex 4HL Water Adj 1600866-001 Ref 1600866-001
Hose Isolite/MC2 White 1600314-001 Ref 1600314-001
Hose 4VR400 Grey Midwest 1600439-050 Ref 1600439-050
Hose MC2 E Grey 1600516-001 Ref 1600516-001
COUPLING UNIFIX 4VL Midwest 1600992-001 Ref 1600992-001
Coupling Unifix 4H Us 1600087-001 Ref 1600087-001
Hose 5 Hole L Grey Midwest 1043348-001 Ref 1043348-001
Tur Prestige LK 1600734-001 Ref 1600734-001
Hose MX2 400 Surf 6 1600783-001 Ref 1600783-001
Coupling Eolia B 4H 1600648-001 Ref 1600648-001
Hose Isolite / MC2 Black 1600297-001 Ref 1600297-001
Hose B-4VX Grey 1600428-001 Ref 1600428-001
HOSE MCX GREY 20.2x40 1600854-001 Ref 1600854-001
Hose 6 Hole L Grey Midwest 1043345-001 Ref 1043345-001
Coupling Unifix 4H L 1600363-001 Ref 1600363-001
Tur Bora LK 1600732-001 Ref 1600732-001
Showing 1-50 of 67
FDA establishments
- Bien-Air Portugal Unipessoal LDA Maia Porto · PT FEI 3013576763
What BIEN-AIR PORTUGAL, UNIPESSOAL, LDA makes
Bien-Air Portugal produces pneumatic dental power tools, including motorized handpieces, remotely-driven drilling systems, and associated components like hose assemblies and couplers. Their offerings include specialized handpieces for surgical and restorative procedures, as well as motorless components and high-pressure air-driven systems for dental applications.
The company’s products are classified under Class I devices and are listed in the FDA’s Unique Device Identifier (UDI) database. Bien-Air Portugal is based in the United States.
Frequently asked questions
What types of medical devices does Bien-Air Portugal manufacture?
Bien-Air Portugal specializes in pneumatic dental power tools, which are air-driven systems used in dental procedures. Their product line includes motorized handpieces for drilling and surgical tasks, remotely-driven dental drilling systems, hose assemblies for air and water delivery, and specialized couplers that connect handpieces to air supply lines. These tools are designed for precision in restorative and surgical dental work.
Where is Bien-Air Portugal based?
Bien-Air Portugal is headquartered in the United States. The company focuses on developing and manufacturing dental power tools tailored for professional use in dental clinics and practices.
Which regulatory registries list Bien-Air Portugal’s devices?
Bien-Air Portugal’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Bien-Air Portugal’s devices classified under medical device regulations?
Bien-Air Portugal’s devices fall under Class I classification, which typically includes low-risk medical devices like dental handpieces, hoses, and couplers. Class I devices are generally considered to pose minimal risk to patients and are subject to fewer regulatory controls compared to higher-risk categories, though they must still meet safety and performance standards.
Information
- Country
- US
- Website
- bienair.com
- [email protected]
- Phone
- +1 949-477-6050
- DUNS number
- 338234588