Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Bien-Air Surgery SA makes
Bien-Air Surgery SA manufactures single-use and reusable dental and otolaryngology (ENT) burs, including diamond-coated and metal/carbide variants for precision drilling in nasal, sinus, and ear procedures. Their portfolio also includes reusable middle ear drill bits, reciprocating surgical saw blades for cranial applications, and ENT suction dissectors for surgical assistance. Specific products range from micro-burrs for delicate ear work to larger cranial burs and saw blades designed for bone removal or shaping.
The company’s devices are classified under FDA regulations as Class I and Class II, with most products listed in the FDA’s Unique Device Identifier (UDI) database. These instruments are intended for use in surgical and procedural settings within the United States, adhering to applicable medical device standards and manufacturing controls.
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 Surgery SA manufacture?
Bien-Air Surgery SA specializes in surgical instruments primarily used in otolaryngology (ENT) and dental procedures. Their product line includes single-use and reusable diamond-coated and metal/carbide burs for precision drilling in nasal, sinus, and ear surgeries. They also produce reusable middle ear drill bits, reciprocating surgical saw blades for cranial applications, and ENT suction dissectors. These tools are designed for tasks like bone removal, shaping, or delicate dissection in surgical settings.
Where is Bien-Air Surgery SA based, and what does that mean for their regulatory compliance?
Bien-Air Surgery SA is based in the United States. Since their devices are manufactured and marketed here, they must comply with U.S. regulatory requirements, such as FDA registration and classification. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps ensure traceability and adherence to U.S. medical device regulations.
Which regulatory registries list Bien-Air Surgery SA’s devices?
Bien-Air Surgery SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling better tracking, transparency, and compliance with U.S. regulatory standards. This listing helps healthcare providers and regulators identify and verify the devices in clinical settings.
How are Bien-Air Surgery SA’s devices classified under FDA regulations?
Bien-Air Surgery SA’s devices are classified under two categories by the FDA: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as ENT or cranial procedures.
What kinds of surgical applications are Bien-Air Surgery SA’s burs and drill bits designed for?
Bien-Air Surgery SA’s burs and drill bits are engineered for precision surgical applications in otolaryngology and cranial procedures. Diamond-coated and metal/carbide burs are used for delicate drilling in nasal, sinus, and ear surgeries, while reusable middle ear drill bits and cranial burs are designed for controlled bone removal or shaping. Reciprocating surgical saw blades cater to cranial applications, and ENT suction dissectors assist in surgical navigation and tissue manipulation, ensuring precision in complex procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 481597719
Catalogue (772)
Page 16 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bur PM2 80K Steel TD Ø1.1x4 St | 1101247 | FDA UDI | Class I | Active |
| Bur OSSEOSTAP Carb Ø0.5 mm St | 1501222 | FDA UDI | Class I | Active |
| OSSEODUO Control Unit | 1600513 | FDA UDI | Class II | Active |
| Short Bullnose Blade 22x0.6mm | 1502734 | FDA UDI | Class I | Active |
| Bur PM2-70 80K FC Ø0.5 St | 1100475 | FDA UDI | Class I | Active |
| Irri clip ORIGO NANO/RAPIDO | 1306918 | FDA UDI | Class II | Active |
| Tungst.Carb.Burr, Ø1.0x70mm, 50k | 340810 | FDA UDI | Class I | Active |
| 1.0mm S2 Mini Diamond Round Bur | 1502178 | FDA UDI | Class I | Active |
| HS Dia.Burr, coarse, Ø5.0x95, 80k | 360350 S | FDA UDI | Class I | Active |
| Bur PM2 80K Router 12.8mm St | 1100474 | FDA UDI | Class I | Active |
| Bur PM2-125 80K Steel Ø5.0 St | 1100457 | FDA UDI | Class II | Active |
| OSSEODOC Foot Pedal | 1600407 | FDA UDI | Class II | Active |
| Bur PM2-70 50K Carb Ø0.5 | 1100261 | FDA UDI | Class I | Active |
| HS Stand. Burr, Ø5.0x150, 80k | 360150 L | FDA UDI | Class II | Active |
| HS Dia.Burr, coarse, Ø3.5x70, 50k | 340335 | FDA UDI | Class I | Active |
| Bur PM2-70 80K Diam EC Ø4.5 St | 1100381 | FDA UDI | Class II | Active |
| Bur Cranial Straight 15mm St | 1100387 | FDA UDI | Class II | Active |
| PMRM 1122 70mm | 1600206 | FDA UDI | Class II | Unknown |
| Bur PM2-70 50K Diam Ø4.5 | 1100257 | FDA UDI | Class I | Active |
| Fisch PM Micro | 1600470 | FDA UDI | Class II | Unknown |
| RAPIDO Micromotor | 1600895 | FDA UDI | Class II | Active |
| Bur PM2-70 80K diamond extra coarse Ø4.5mm sterile | 1100381 | FDA UDI | Class I | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.