Question 1

What types of medical devices does Bien-Air Dental SA manufacture?

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
SET iCHIROPRO SU + PM 1:2	1700484-001	EUDAMEDFDA UDI	Class IIa	Active
Maint Lubrimed Cartridge	1600037-006	EUDAMEDFDA UDI	Class I	Active
Touchscreen portrait + SD	1503099-005	EUDAMED	Class IIa	Active
CA 20:1 LKM Micro-Series	1600874-001	EUDAMEDFDA UDI	Class IIa	Active
CA 20:1L Micro-Series	1600873-001	EUDAMEDFDA UDI	Class IIa	Active
CABLE MX-i LED 1.4m_100781	1601160-001	EUDAMED	Class IIa	Active
Maint Greaser	1000003-001	EUDAMEDFDA UDI	Class I	Active
Hose MCX Grey	1600756-001	EUDAMEDFDA UDI	Class IIa	Active
Hose Mcx 400°_100781	1601097-001	EUDAMED	Class IIa	Active
Console Optima Mcx Orange	1600966-001	EUDAMEDFDA UDI	Class IIa	Active
Hose Mx2 400°_100781	1600773-001	EUDAMEDFDA UDI	Class IIa	Active
Board Dmx3 Mcx 100 Rpm	1600903-00B	EUDAMED	Class IIa	Active
HOSE MCX Grey 400° Ø20.2x40	1601096-001	EUDAMEDFDA UDI	Class IIa	Active
CA 20:1 L Micro-Series	600692-001	EUDAMEDFDA UDI	Class IIa	Active
SET Chiropro 3rd Gen CA 20:1 L KM	1700736-001	EUDAMEDFDA UDI	Class IIa	Active
Maint Aqua Care Box Of 6 Cans	1600617-006	EUDAMED	Class I	Active
SET iCHIROPRO + CA 20:1 L MS	1700440-001	EUDAMEDFDA UDI	Class IIa	Active
Air motor AQUILON 830 SR	1600362-001	EUDAMEDFDA UDI	Class IIa	Active
PM 1:1 Micro-Series	1600693-001	EUDAMEDFDA UDI	Class IIa	Active
SET Chiropro 3rd Gen.	1700708-001	EUDAMEDFDA UDI	Class IIa	Active
SET Chiropro 3rd Gen KM	1700737-001	EUDAMEDFDA UDI	Class IIa	Active
Hose 4vlm Grey	1600102-001	EUDAMEDFDA UDI	Class IIa	Active
TU Bora 2 LED	1601152-001	EUDAMEDFDA UDI	Class IIa	Active
BOARD DMX3 M BtoB	1502123-001	EUDAMED	Class IIa	Active
Xpu Mmotor No Light	1601244-001	EUDAMEDFDA UDI	Class IIa	Active
SET Chiropro+ 3rd Gen KM	1700739-001	EUDAMEDFDA UDI	Class IIa	Active
SET Chiropro+ 3rd Gen	1700710-001	EUDAMEDFDA UDI	Class IIa	Active
Set Global Display	1700888-001	EUDAMED	Class IIa	Active
Set Osseocare Pro Km_102971	1700493-001	EUDAMED	Class IIa	Active
Tur Tornado LK	1600907-001	EUDAMEDFDA UDI	Class IIa	Active
Mot Mx-I Led 3rd Gen	1601008-001	EUDAMEDFDA UDI	Class IIa	Active
Hose 4vlm11 Grey	1600097-001	EUDAMEDFDA UDI	Class IIa	Active
Ca 1:2.5 L	1601163-001	EUDAMEDFDA UDI	Class IIa	Active
Set Biopower	1700784-001	EUDAMEDFDA UDI	Class IIa	Active
Console iOptima INT 1xMX2	1601074-001	EUDAMEDFDA UDI	Class IIa	Active
Mot MC3 (LED)	1600680-001	EUDAMEDFDA UDI	Class IIa	Active
Ca Prima 1:1 L	1601267-001	EUDAMEDFDA UDI	Class IIa	Active
Ca Prima 1:121	1601237-001	EUDAMEDFDA UDI	Class IIa	Active
Hose Isolite Water Adj Grey	1600134-001	EUDAMEDFDA UDI	Class IIa	Active
Console iChiropro	1600784-001	EUDAMEDFDA UDI	Class IIa	Active
SET iCHIROPRO SURGERY	1700485-001	EUDAMEDFDA UDI	Class IIa	Active
Ca Prima 1:1 L Ms	1601236-001	EUDAMEDFDA UDI	Class IIa	Active
SET iChiropro+CA 20:1 L KM MS	1700505-001	EUDAMEDFDA UDI	Class IIa	Active
Hose Light Motor	1601248-001	EUDAMEDFDA UDI	Class IIa	Active
SET Chiropro+ 3rd Gen CA 20:1 L KM	1700738-001	EUDAMEDFDA UDI	Class IIa	Active
SET Chiropro 3rd Gen CA 20:1 L	1700707-001	EUDAMEDFDA UDI	Class IIa	Active
Console iOptima INT 2xMX2	1601075-001	EUDAMEDFDA UDI	Class IIa	Active
I-Surge Led	1601245-001	EUDAMEDFDA UDI	Class IIa	Active
Ca 1:1 L	1600384-001	EUDAMEDFDA UDI	Class IIa	Active
Mot MCX LED	1600751-001	EUDAMEDFDA UDI	Class IIa	Active

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