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Sign in to claim this brandBIEN-AIR PORTUGAL, UNIPESSOAL, LDA
US
Last updated May 24, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bienair.com
- —
- —
- [email protected]
- Phone
- +1 949-477-6050
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 338234588
Catalogue (56)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Set MC3 LED + Hose for Kavo | 1700447-001 | FDA UDI | Class I | Active |
| Hose 4VLM11 Black | 1600098-001 | FDA UDI | Class I | Active |
| Hose 4vlm10 Black | 1600103-001 | FDA UDI | Class I | Active |
| Set MC3 LED + Hose for Sirona | 1700448-001 | FDA UDI | Class I | Active |
| Coupling Socket B 4b-Vx | 1600278-001 | FDA UDI | Class I | Active |
| Mot MC2 40 GT IR | 1600633-001 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bien-Air Portugal Unipessoal LDA Maia Porto · PT FEI 3013576763