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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 2 of 7
DeviceModel / ReferenceRegistriesClassStatus
PM 10:1 Prophy 1600289-001
FDA UDI
Class IActive
Ca 10:1 1600425-001
FDA UDI
Class IActive
Mot MX 1600375-001
FDA UDI
Class IActive
Console Chiropro L Premium 1600855-001
FDA UDI
Class IActive
KIT CA ENDO + License Code 1700733-001
FDA UDI
Class IActive
TU Tornado X L 1601085-001
FDA UDI
Class IActive
Hose Mcx Grey (special Length) 1600756-0
FDA UDI
Class IActive
Tur Prestige L + Unifix 4H L 1700184-001
FDA UDI
Class IActive
Console Optima Mx Int 1600534-001
FDA UDI
Class IActive
Tur Prestilina 1600372-001
FDA UDI
Class IActive
Mot MX LED 1600605-001
FDA UDI
Class IActive
PM 1:1 Diamline 1600508-001
FDA UDI
Class IActive
Ca Nova 1:1l Ms 1601011-001
FDA UDI
Class IActive
Set Console CHIROPRO L US PREMIUM WL 1700889-001
FDA UDI
Class IActive
Mot Mc2 Sr 1600074-001
FDA UDI
Class IActive
Mc3 Lk + 4vlm 1700336-001
FDA UDI
Class IActive
Set Biopower 1700784-001E
FDA UDI
Class IActive
Set Aquilon830 IR NC + Unifix 3H 1700058-001
FDA UDI
Class IActive
Maint Lubrifluid (Single Can) 1600064-001
FDA UDI
Class IActive
Set Optima Mx2 Educational 6 1700817-001
FDA UDI
Class IActive
Set Optima MX2 INT PRO 1700386-001
FDA UDI
Class IActive
Set Optima MX2 PROINT 8 1700422-001
FDA UDI
Class IActive
Maint Aquacare (Single Can) 1600617-001
FDA UDI
Class IActive
Set iOptima W/O MOTOR + BRACKET 1700564-001
FDA UDI
Class IActive
Set Students Bausa 6 1700795-001
FDA UDI
Class IActive
Set Optima Mx2 Educational 6 1700817-0
FDA UDI
Class IActive
PM 1:1 Ext Spray Lares 1601071-001
FDA UDI
Class IActive
Set iOptima int-1xMX2-Full 1700704-001
FDA UDI
Class IActive
Set Chiropro L Us 1700349-001
FDA UDI
Class IActive
Ca 30:1 Ext Spray Welded 1600479-001
FDA UDI
Class IActive
Tur Bora L Blackline 1600637-001
FDA UDI
Class IActive
Console Optima MX2 INT 1600715-001
FDA UDI
Class IActive
Set Optima MX2 PRO INT 2M 1700425-001
FDA UDI
Class IActive
Set iOptima + CA +:5L MS 1700569-001
FDA UDI
Class IActive
Set Optima INT PRO / 100586 1700540-001
FDA UDI
Class IActive
Set Optima MX2 INT PRO + TR 1700390-001
FDA UDI
Class IActive
Console Biopower 1601147-001E
FDA UDI
Class IActive
Set Osseocare Pro CA 20: L MS KM 1700471-001
FDA UDI
Class IActive
CA 1:1 Ext Spray 1600200-001
FDA UDI
Class IActive
Set Optima INT DMCX 2M 1700487-001
FDA UDI
Class IActive
Mot MX-i LED NB 1600875-001
FDA UDI
Class IActive
Ca Nova 1:1l 1601012-001
FDA UDI
Class IActive
Set Students Bausa 8 1700800-0
FDA UDI
Class IActive
Set Chiropro + CA 20:1 1700388-001
FDA UDI
Class IActive
Set iOptima int-MX2+MXi-Full 1700706-001
FDA UDI
Class IActive
Set iOptima 1700544-001
FDA UDI
Class IActive
Set iOptima int-2xMX2-Full 1700705-001
FDA UDI
Class IActive
Set Aquilon830 SR + Unifix 3H 1700212-001
FDA UDI
Class IActive
Tur Bora L + Unifix 4H L 1700189-001
FDA UDI
Class IActive
Console Chiropro L Premium 1600829-001
FDA UDI
Class IActive

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