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Bien-Air Dental SA

Switzerland·CH-MF-000014661

Last updated September 17, 2026

What Bien-Air Dental SA makes

Bien-Air Dental SA manufactures dental surgical power tools, including pneumatic and motorized handpieces, motorless components, and remotely-driven drilling systems. Their portfolio also includes dental delivery systems, lubricants for surgical instrument maintenance, and pneumatic hoses for power tools. Examples include reciprocating microsaws, micro-series drills, and implantology consoles for dental procedures.

The company’s devices are classified as Class I and Class IIa under EU and FDA regulations, with listings in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s Unique Device Identifier (UDI) registry. The manufacturer is based in Switzerland.

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 Dental SA manufacture?

Bien-Air Dental SA specializes in dental surgical power tools, including pneumatic and motorized handpieces, motorless components, and remotely-driven drilling systems. Their product range also covers dental delivery systems, lubricants for maintaining surgical instruments, and pneumatic hoses for power tools. These devices are designed for dental procedures such as drilling, implantology, and microsurgery.

Where is Bien-Air Dental SA based, and what is its primary focus?

Bien-Air Dental SA is based in Switzerland. The company focuses on developing and manufacturing dental surgical power tools and related accessories, catering specifically to dental professionals for procedures requiring precision and efficiency.

Which regulatory registries list Bien-Air Dental SA’s devices?

Bien-Air Dental SA’s devices are listed in multiple regulatory databases, including the EUDAMED database for European Union compliance, the FDA’s 510(k) premarket notifications registry in the United States, and the FDA’s Unique Device Identifier (UDI) registry. These listings help ensure traceability and regulatory transparency for their products.

How are Bien-Air Dental SA’s devices classified under EU and FDA regulations?

Bien-Air Dental SA’s devices are classified as either Class I or Class IIa under EU and FDA regulations. Class I devices generally pose minimal risk and require basic compliance measures, while Class IIa devices involve a moderate level of risk and require additional validation to ensure safety and performance, such as through clinical evaluations or performance testing.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Switzerland
Address
60, Länggasse, Biel/Bienne, Switzerland
Website
www.dental.bienair.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1 949-477-6050
PRRC Contact
Carine Bériet
EUDAMED SRN
CH-MF-000014661
FDA FEI Number
3002762033
DUNS Number
480082080

Catalogue (302)

Page 3 of 7
DeviceModel / ReferenceRegistriesClassStatus
Set Students Bausa 13 1700842-001
FDA UDI
Class IActive
Ca 10:1 L 1600385-001
FDA UDI
Class IActive
Console Osseocare 1600871-001
FDA UDI
Class IActive
iChiropro Surgery APP 1400052
FDA UDI
Class IActive
Optima Mx2 Int Dmx3 1 Motor 1700786-001
FDA UDI
Class IActive
Chiropro L US 1600697-001
FDA UDI
Class IActive
Set Optima INT DMCX 1700486-001
FDA UDI
Class IActive
Tur Prestige + Unifix 4H 1700186-001
FDA UDI
Class IActive
Set MC3 LED + 4VLM-11 1700446-001
FDA UDI
Class IActive
Mc3 Lk + 4vr400 1700046-001
FDA UDI
Class IActive
Footctrl Chiropro980 1600281-001
FDA UDI
Class IActive
Set Chiropro 1700387-001
FDA UDI
Class IActive
Set Students Bausa 5 1700794-001
FDA UDI
Class IActive
Set Oms 1700769-001
FDA UDI
Class IActive
Console Osseocare Us 1600872-001
FDA UDI
Class IActive
Set Optima MX2 INT PLUS + TR 1700394-001
FDA UDI
Class IActive
Set Optima MX2 PRO INT 1700421-001
FDA UDI
Class IActive
Console iOptima 1600926-001
FDA UDI
Class IActive
Optima Mx2 Int Dmx3 2 Motors 1700785-001
FDA UDI
Class IActive
Set Proimplant 3rd Gen Ca 20:1 1700774-001
FDA UDI
Class IActive
Pm Ca 1:1 L S-Nxc 1600938-0
FDA UDI
Class IActive
Set iOptima int-1xMX2-Light 1700730-001
FDA UDI
Class IActive
Set Aquilon830 IR C + Unifix 4H 1700211-001
FDA UDI
Class IActive
Lubricare Maintenance System 1600915-001
FDA UDI
Class IActive
Set Optima MX2 INT PLUS 1700393-001
FDA UDI
Class IActive
Set Students Bausa 13 1700842-0
FDA UDI
Class IActive
Tur Bora + Unfix 3H 1700187-001
FDA UDI
Class IActive
Pm Ca 20:1 L Ro 104936 1601408-001
FDA UDI
Class IActive
CA 1:1 L Micro-Series Lares 1601059-001
FDA UDI
Class IActive
Console Optima Mcx White Edu 1600959-001E
FDA UDI
Class IActive
Set Optima MX2 INT PRO 2M 1700392-001
FDA UDI
Class IActive
Ca 1:2.5 L Ms 1601055-001
FDA UDI
Class IActive
Set Students Bausa 8 1700800-001
FDA UDI
Class IActive
PM CA 1:5L EVO15 Micro-Series 1600940-001
FDA UDI
Class IActive
Optima Mcx Int Dmx3 1 Motor 1700787-001
FDA UDI
Class IActive
Set Optima MX2 INT PRO + 24-32V 1700391-001
FDA UDI
Class IActive
iOptima/Optima support bracket for installation beside dental unit 1501988-001
FDA UDI
Class IActive
Optima MX2 INT PRO 1700545-001
FDA UDI
Class IActive
Set Chiropro L Us Ca 20:1 L 1700350-001
FDA UDI
Class IActive
Console Chiropro L 1600679-001
FDA UDI
Class IActive
Set Optima MX2 PRO INT 2M 8 1700426-001
FDA UDI
Class IActive
Chiropro 980 4 Buttons Foot Control 1600391-001
FDA UDI
Class IActive
iOptima APP 1400063
FDA UDI
Class IActive
CA 15:1 Prophy 1600290-001
FDA UDI
Class IActive
CA 1:1 Ext Spray Welded 1600603-001
FDA UDI
Class IActive
Set iOptima int-MX2+MXi-Light 1700732-001
FDA UDI
Class IActive
CA 1:5 L Lares 1601058-001
FDA UDI
Class IActive
PM HP 1:1 sp. ext. 1600052-0
FDA UDI
Class IActive
PM Prolab 1600430-001
FDA UDI
Class IActive
Mot Isolite LI 1600079-001
FDA UDI
Class IActive

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