Is this your brand? Sign in to claim ownership.
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 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hose 4vlm11 Surf6 Adec | 1043807-001 | FDA UDI | Class I | Active |
| Hose 4vr400 Surf6 Adec | 1600423-001 | FDA UDI | Class I | Active |
| Hose Mc Medicamat | 1600272-001 | FDA UDI | Class I | Active |
| Tur Prestige | 1600379-001 | FDA UDI | Class I | Active |
| Hose T LE White | 1600131-001 | FDA UDI | Class I | Active |
| Mot MC2 GT AV | 1600075-001 | FDA UDI | Class I | Active |
| TY MX2 400° calotte Ø20.2x40 | 1600809-0 | FDA UDI | Class I | Active |
| Ca Endo | 1600955-001 | FDA UDI | Class I | Active |
| Tur Bora L | 1600382-001 | FDA UDI | Class I | Active |
| Coupling Unifix 4h L Water Adj | 1600086-001 | FDA UDI | Class I | Active |
| HOSE B-4VX GREY new | 1600537-001 | FDA UDI | Class I | Active |
| Hose Isolite/Mc2 Swivel Black | 1600299-001 | FDA UDI | Class I | Active |
| HOSE 4VX GREY (16x27) | 1600536-001 | FDA UDI | Class I | Active |
| Hose MX2 Grey | 1600678-001 | FDA UDI | Class I | Active |
| Hose Scaler Powercare | 1600675-001 | FDA UDI | Class I | Active |
| Hose 4VX Grey | 1600387-001 | FDA UDI | Class I | Active |
| Cable MX LED | 1600606-001 | FDA UDI | Class I | Active |
| Hose MCX Grey ADEC | 1600820-001 | FDA UDI | Class I | Active |
| Coupling Multiflex 4h L | 1600902-001 | FDA UDI | Class I | Active |
| Hose Isolite/Mc2 Swivel White | 1600316-001 | FDA UDI | Class I | Active |
| Prestige - 5 Hole W/O Coupler | 1600046-001 | FDA UDI | Class I | Active |
| Tur Bora L LED | 1600638-001 | FDA UDI | Class I | Active |
| Hose MC E Black | 1600124-001 | FDA UDI | Class I | Active |
| Coupl Multiflex 4hl Water Adj | 1600866-001 | FDA UDI | Class I | Active |
| Hose Isolite/Mc2 White | 1600314-001 | FDA UDI | Class I | Active |
| Hose 4vr400 Grey Midwest | 1600439-050 | FDA UDI | Class I | Active |
| Hose MC2 E Grey | 1600516-001 | FDA UDI | Class I | Active |
| COUPLING UNIFIX 4VL Midwest | 1600992-001 | FDA UDI | Class I | Active |
| Coupling Unifix 4h Us | 1600087-001 | FDA UDI | Class I | Active |
| Hose 5 Hole L Grey Midwest | 1043348-001 | FDA UDI | Class I | Active |
| Tur Prestige LK | 1600734-001 | FDA UDI | Class I | Active |
| Hose Mx2 400 Surf 6 | 1600783-001 | FDA UDI | Class I | Active |
| Coupling Eolia B 4h | 1600648-001 | FDA UDI | Class I | Active |
| Hose Isolite / MC2 Black | 1600297-001 | FDA UDI | Class I | Active |
| Hose B-4VX Grey | 1600428-001 | FDA UDI | Class I | Active |
| HOSE MCX GREY 20.2x40 | 1600854-001 | FDA UDI | Class I | Active |
| Hose 6 Hole L Grey Midwest | 1043345-001 | FDA UDI | Class I | Active |
| Coupling Unifix 4H L | 1600363-001 | FDA UDI | Class I | Active |
| Tur Bora LK | 1600732-001 | FDA UDI | Class I | Active |
| Coupling Socket B-MX2 | 1600753-001 | FDA UDI | Class I | Active |
| Hose 4vx Surf6 Adec | 1600695-001 | FDA UDI | Class I | Active |
| Hose B-4vr 400 Grey L 1700 | 1600458-001 | FDA UDI | Class I | Active |
| Hose B-4VR400 Grey | 1600398-001 | FDA UDI | Class I | Active |
| Coupling Socket B 4b-Vx | 1600280-001 | FDA UDI | Class I | Active |
| Coupling Unifix 4H | 1600082-001 | FDA UDI | Class I | Active |
| Tur Prestige L LED | 1600641-001 | FDA UDI | Class I | Active |
| Tur Prestige L | 1600380-001 | FDA UDI | Class I | Active |
| Coupling Unifix 3H | 1600081-001 | FDA UDI | Class I | Active |
| Hose 4 Hole L M 10 Grey B | 1600246-001 | FDA UDI | Class I | Active |
| Tur Bora | 1600381-001 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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