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
Mc Mx2	1600677-0	FDA UDI	Class I	Active
Set B-4VR400 Grey + Socket B	1700043-001	FDA UDI	Class I	Active
Console Proimplant	1600730-001	FDA UDI	Class I	Active
Tur Prestige + Unifix 3H	1700185-001	FDA UDI	Class I	Active
Set Proimplant 3rd Gen Ca 20:1 L	1700768-001	FDA UDI	Class I	Active
Wireless Footctrl + Dongle	1601192-001	FDA UDI	Class I	Active
Pm 1:1 Twist Drill	1601190-001	FDA UDI	Class I	Active
Set Students Bausa 7	1700796-0	FDA UDI	Class I	Active
Set Osseocare CA 20:1 L MS	1700472-001	FDA UDI	Class I	Active
BOARD DMX3 iOPTIMA INT BOX	1601015-001	FDA UDI	Class I	Active
Set MC3 IR + 4VLM-11 Grey	1700337-001	FDA UDI	Class I	Active
Set Students Bausa 14	1700857-0	FDA UDI	Class I	Active
CA 1:5 L Micro-Series	1600690-001	EUDAMEDFDA UDI	Class IIa	Active
Console Optima Mcx Pink	1600968-001	EUDAMEDFDA UDI	Class IIa	Active
Board Dmx3 Full Open	1600903-00A	EUDAMEDFDA UDI	Class IIa	Active
Ca 1:2.5 L Ms	1601164-001	EUDAMEDFDA UDI	Class IIa	Active
Ca 20:1	1600632-001	EUDAMEDFDA UDI	Class IIa	Active
Console Optima Mx2 Int 104761	1601259-001	EUDAMED	Class IIa	Active
Mot Isolite LK	1600078-001	EUDAMEDFDA UDI	Class IIa	Active
Touchscreen paysage + SD	1503105-005	EUDAMED	Class IIa	Active
SET iCHIROPRO	1700439-001	EUDAMEDFDA UDI	Class IIa	Active
Console iOptima INT MX2 MX-i	1601076-001	EUDAMEDFDA UDI	Class IIa	Active
Ca Nova 1:5l	1601139-001	EUDAMEDFDA UDI	Class IIa	Active
Ca 20:1 L Km	1600785-001	EUDAMEDFDA UDI	Class IIa	Active
CA Midwest® lmplant 20:1 L	1601411-001	EUDAMEDFDA UDI	Class IIa	Active
Hose Isolite/Mc2 Swivel Grey	1600298-001	EUDAMEDFDA UDI	Class IIa	Active
Ca Nova 1:1l	1601137-001	EUDAMEDFDA UDI	Class IIa	Active
Console Chiropro PLUS 3rd Gen.	1600994-001	EUDAMEDFDA UDI	Class IIa	Active
Mot MC3 LK	1600077-001	EUDAMEDFDA UDI	Class IIa	Active
Board Dmx3 Can Box	1600982-005	EUDAMED	Class IIa	Active
Hose Isolite/Mc2 Coiled Black	1600315-001	EUDAMEDFDA UDI	Class IIa	Active
CABLE MX-i LED 0.8m_100781	1601161-001	EUDAMED	Class IIa	Active
Xpu Mmotor Light	1601242-001	EUDAMEDFDA UDI	Class IIa	Active
Ca 1:5 L	1600386-001	EUDAMEDFDA UDI	Class IIa	Active
Cable Mx-I Led 3rd Gen	1601009-001	EUDAMEDFDA UDI	Class IIa	Active
Hose 4vr400 Grey	1600397-001	EUDAMEDFDA UDI	Class IIa	Active
Tur Black Pearl ECO 3H	1600039-001	EUDAMEDFDA UDI	Class IIa	Active
Hose Isolite/Mc2 Grey	1600120-001	EUDAMEDFDA UDI	Class IIa	Active
Mot MC3 IR	1600071-001	EUDAMEDFDA UDI	Class IIa	Active
Ca 20:1 L	1600598-001	EUDAMEDFDA UDI	Class IIa	Active
Mot Aquilon 830 Ir Nc	1600070-001	EUDAMEDFDA UDI	Class IIa	Active
Ca Nova 1:1l Ms	1601136-001	EUDAMEDFDA UDI	Class IIa	Active
Board Dmcx	1600811-001	EUDAMEDFDA UDI	Class IIa	Active
CABLE MX-i LED	1601069-001	EUDAMEDFDA UDI	Class IIa	Active
Chiropro L System	K092214	FDA 510(k)	Class I	Active
Mot MX2	1600677-001	EUDAMEDFDA UDI	Class IIa	Active
HOSE MX2 400 GREY 20.2x40	1600809-001	EUDAMEDFDA UDI	Class IIa	Active
Tur Tornado S LED	1600933-001	EUDAMEDFDA UDI	Class IIa	Active
Console iChiropro Surgery	1600883-001	EUDAMEDFDA UDI	Class IIa	Active
Pm 1:2	1600436-001	EUDAMEDFDA UDI	Class IIa	Active

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