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
Maint Spraynet Single Can	1600036-001	EUDAMEDFDA UDI	Class I	Active
Console Optima Mcx Blue	1600965-001	EUDAMEDFDA UDI	Class IIa	Active
Cable I-Surge Led	1601246-001	EUDAMEDFDA UDI	Class IIa	Active
Tur Tornado LED	1600908-001	EUDAMEDFDA UDI	Class IIa	Active
Hose Isolite Swivel Grey	1600132-001	EUDAMEDFDA UDI	Class IIa	Active
Cable Mx Led 3m	1600881-001	EUDAMEDFDA UDI	Class IIa	Active
Dmx3 Can	1502140-001	EUDAMED	Class IIa	Active
BOARD DMX3 M BtoW	1502121-010	EUDAMED	Class IIa	Active
Ca Nova 1:5l Ms	1601138-001	EUDAMEDFDA UDI	Class IIa	Active
Hose MX2 400 Grey	1600700-001	EUDAMEDFDA UDI	Class IIa	Active
Console Global Display	1601275-001	EUDAMED	Class IIa	Active
HOSE MCX GREY 2.2m	1600920-001	EUDAMEDFDA UDI	Class IIa	Active
Tur Black Pearl ECO 4H	1600040-001	EUDAMEDFDA UDI	Class IIa	Active
Mot MC2 IR	1600073-001	EUDAMEDFDA UDI	Class IIa	Active
Ca 1:5	1600325-001	EUDAMEDFDA UDI	Class IIa	Active
Tur Tornado S LK	1600932-001	EUDAMEDFDA UDI	Class IIa	Active
Tur Boralina	1600373-001	EUDAMEDFDA UDI	Class IIa	Active
Xpu Mmotor Cable	1601243-001	EUDAMEDFDA UDI	Class IIa	Active
TU Bora 2 LK	1601153-001	EUDAMEDFDA UDI	Class IIa	Active
CA 1:1 L Micro-Series	1600691-001	EUDAMEDFDA UDI	Class IIa	Active
PM 1:1 Ext Spray	1600052-001	EUDAMEDFDA UDI	Class IIa	Active
Ca Prima 1:1	1601235-001	EUDAMEDFDA UDI	Class IIa	Active
Console Optima Mcx Green	1600967-001	EUDAMEDFDA UDI	Class IIa	Active
Console Biopower	1601147-001	EUDAMEDFDA UDI	Class IIa	Active
CA 20:1 L KM Micro-Series	1600786-001	EUDAMEDFDA UDI	Class IIa	Active
Set Meg-Engine Ii	1700750-001	EUDAMEDFDA UDI	Class IIa	Active
Hose Mcx 400 Grey	1601081-001	EUDAMEDFDA UDI	Class IIa	Active
Set Chiropro 3rd Gen CA 20:1 L WL	1700890-001	EUDAMED	Class IIa	Active
Maint Spraynet (box 6 Cans)	1600036-006	EUDAMEDFDA UDI	Class I	Active
Console Optima Mcx White	1600959-001	EUDAMEDFDA UDI	Class IIa	Active
SET Chiropro+ 3rd Gen CA 20:1 L	1700709-001	EUDAMEDFDA UDI	Class IIa	Active
Set Chiropro+ 3rd CA 20:1 L WL	1700891-001	EUDAMED	Class IIa	Active
SET iCHIROPRO CA 20:1 L WL	1700892-001	EUDAMED	Class IIa	Active
HOSE 4VLM Ø11 grey_100130	1600986-001	EUDAMED	Class IIa	Active
Hose B-Mx2 Grey	1600762-001	EUDAMEDFDA UDI	Class IIa	Active
Light Motor	1601247-001	EUDAMEDFDA UDI	Class IIa	Active
IDUP Board	1601196-005	EUDAMEDFDA UDI	Class IIa	Active
BOARD DMX3 M Bornier	1502122-010	EUDAMED	Class IIa	Active
Mot MX-i LED	1600755-001	EUDAMEDFDA UDI	Class IIa	Active
Maint Greaser	1000003-050	EUDAMED	Class I	Active
Mot MCX	1600780-001	EUDAMEDFDA UDI	Class IIa	Active
Mot Isolite (LED)	1600681-001	EUDAMEDFDA UDI	Class IIa	Active
Pm 1:1	1600383-001	EUDAMEDFDA UDI	Class IIa	Active
Hose B-Mcx Grey	1600824-001	EUDAMEDFDA UDI	Class IIa	Active
Dmx3 Can	1502140-010	EUDAMED	Class IIa	Active
Ca 1:1	1600424-001	EUDAMEDFDA UDI	Class IIa	Active
Mot MX-i	1600825-001	EUDAMEDFDA UDI	Class IIa	Active
CA eLINE 1:1 L	1601143-001	EUDAMED	Class IIa	Active
Console Chiropro 3rd Gen.	1600995-001	EUDAMEDFDA UDI	Class IIa	Active
CA eLINE 1:5 L	1601144-001	EUDAMED	Class IIa	Active

Bien-Air Dental SA

What Bien-Air Dental SA makes

Frequently asked questions

Information

Catalogue (302)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities