Manufacturer

Bienair

SwitzerlandLegal entities : Bien-Air Dental SA, Bien-Air Surgery SA

Markets : Austria · Belgium · Denmark · Estonia · Finland · France · Germany · Iceland · Italy · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 9 · class I, II · latest in 2022 · see on the FDA website

Public contracts won : Germany 1

EU representative : Bien-Air Europe Sàrl (France)

Website regulatory@bienair.com

6 categories, 35 models including 35 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Various ENT instruments - hardware accessories	Z12149080	0.35mm S2 Mini PERFORATOR BUR93/42 0.5mm S2 Mini CARBIDE ROUND BUR93/42 0.6mm S2 Mini CARBIDE ROUND BUR93/42 0.6mm S2 Mini DIAMOND ROUND BUR93/42 0.7mm S2 Mini CARBIDE ROUND BUR93/42 12 others 0.7mm S2 Mini DIAMOND ROUND BUR93/42 0.8mm S2 Mini CARBIDE ROUND BUR93/42 0.8mm S2 Mini DIAMOND ROUND BUR93/42 1.0mm S2 Mini CARBIDE ROUND BUR93/42 1.0mm S2 Mini DIAMOND ROUND BUR93/42 1.2mm S2 Mini DIAMOND ROUND BUR93/42 1.4mm S2 Mini CARBIDE ROUND BUR93/42 1.4mm S2 Mini DIAMOND ROUND BUR93/42 1.8mm S2 Mini CARBIDE ROUND BUR93/42 1.8mm S2 Mini DIAMOND ROUND BUR 1.8mm S2Mini DIAMOND ROUND BUR93/42 2.3mm S2 Mini CARBIDE ROUND BUR93/42 2.3mm S2 Mini DIAMOND ROUND BUR93/42	IIa 93/42	EUDAMED record Report an error
Instruments for dental treatment units - other	Z12110199	Air motor AQUILON 830 SR 1600362-00193/42 BOARD DMCX3 refs Console Biopower3 refs Console iOptima INT 1xMX23 refs CONSOLE OPTIMA MCX BLUE3 refs 3 others MOT AQUILON 830 IR NC 1600070-00193/42 PM 1:23 refs TU BLACK PEARL ECO 3H3 refs	IIa MDR, 93/42	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	Cable for Perforator Motor PM PERFO Cable ORIGO Control Unit 1601048 ORIGO Foot Pedal 1601082 PM2-A MIS PM2 Handpieces3 refs S120 Cable	I, IIa MDR	EUDAMED record Report an error
Dental treatment units	Z12110101	Console iChiropro2 refs SET BIOPOWER3 refs	IIa MDR	EUDAMED record Report an error
Otological drills	Z12149007	S2 Mini Drill93/42 S2 Mini Foot Pedal S2 Mini drill System93/42	IIa 93/42	EUDAMED record Report an error
Various ENT instruments - other	Z12149099	80K / RAPIDO / PM PERFO Cable Cables3 refs	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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