Manufacturer registered with FDA
Bien-Air Dental, SA
BIENNE, Switzerland. Lists 3 dental device types with FDA across 3 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 318
- 510(k) clearances
- 12009–2009
- Markets registered in
- 13316 registrations outside the US
- Establishments
- 3Switzerland, Portugal
510(k) clearances per year, 2000–2026
Registered in 13 markets
Where regulators' registries name Bien-Air Dental, SA as the manufacturer or the registration holder of a device.
RegisteredHome: SwitzerlandOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bien-Air Dental, SA | 1 clearances | 2009–2009 | Below |
| Canada | Health Canada | Registration holder | BIEN-AIR DENTAL SA | 175 | 2006–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Bien Air Dental SABien-Air Dental SA | 34 | 2007–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Bien-Air Dental SABIEN-AIR DENTAL SA · BIEN-AIR Dental SA | 31 | 2004–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Bien-Air Dental SABIEN AIR DENTAL SA · BIEN-AIR DENTAL SA | 26 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Bien-Air Dental SA | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIEN-AIR DENTAL SABIEN AIR DENTAL SA · Bien-Air Dental SA · +1 | 11 | 2005–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIEN-AIR DENTAL SA | 8 | 2016–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Bien-Air Dental SA | 8 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Bien-Air Dental SA | 5 | — | Pure Global AI |
| China | NMPA | Registration holder | 瑞士彼岸齿科有限公司Bien-Air Dental SABien-Air Dental SA 瑞士彼岸齿科有限公司 | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BIEN AIR DENTAL SA, | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BIEN-AIR DENTAL S.A. | 1 | 2012–2012 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Bien-Air Dental, SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | ADAPTERAQUACAREBUR GUARD HP 1:2 (100 PCES)CACA 1:1CA 1:1 EXT SPRAYCA 1:1 EXT SPRAY WELDEDCA 1:1 LCA 1:1 L EVO15CA 1:1 L EVO15 MICRO-SERIES 188 moreCA 1:1 L LARESCA 1:1 L MICRO-SERIESCA 1:1 L MICRO-SERIES LARESCA 1:2.5 LCA 1:2.5 L MSCA 1:5CA 1:5 LCA 1:5 L EVO15CA 1:5 L EVO15 MICRO-SERIESCA 1:5 L LARESCA 1:5 L MICRO-SERIESCA 1:5 L MICRO-SERIES LARESCA 10:1CA 10:1 LCA 15:1 PROPHYCA 20:1CA 20:1 LCA 20:1 L KMCA 20:1 L KM MICRO-SERIESCA 20:1 L MICRO-SERIESCA 30:1 EXT SPRAYCA 30:1 EXT SPRAY WELDEDCA 8:1CA ENDOCA ENDO + ACTIVATION CODECA EVOCA Midwest® lmplant 20:1 LCA NOVA 1:1LCA NOVA 1:1L MSCA NOVA 1:5LCA NOVA 1:5L MSCA PRIMA 1:1CA PRIMA 1:1 LCA PRIMA 1:1 L MSCA PRIMA 1:121CABLECABLE I-SURGE LEDCOUPL MULTIFLEX® 4HL WATER ADJCOUPLINGCOUPLING EOLIA B 4HCOUPLING MULTIFLEX® 4H LCOUPLING SOCKET BCOUPLING SOCKET B 4B-VXCOUPLING SOCKET B B-MX2COUPLING UNIFIX 3HCOUPLING UNIFIX 4HCOUPLING UNIFIX 4H LCOUPLING UNIFIX 4H L WATER ADJCOUPLING UNIFIX 4H USCOUPLING UNIFIX® 4VL MidwestHOSEHOSE 4 HOLE L BLACK MIDWESTHOSE 4 HOLE L M 10 GREY BHOSE 4 HOLE L SURF6 MIDWESTHOSE 4VLM GREYHOSE 4VLM10 BLACKHOSE 4VLM11 BLACKHOSE 4VLM11 GREYHOSE 4VLM11 SURF6 ADECHOSE 4VR400 GREYHOSE 4VR400 GREY MIDWESTHOSE 4VR400 SURF6 ADECHOSE 4VX GREYHOSE 4VX SURF6 ADECHOSE 5 HOLE L GREY MIDWESTHOSE 6 HOLE L GREY MIDWESTHOSE B-4VR 400 GREY L 1700HOSE B-4VR400 GREYHOSE B-4VX GREYHOSE B-MCX GREYHOSE B-MX2 GREYHOSE ISOLITE WATER ADJ GREYHOSE ISOLITE/MC2 BLACKHOSE ISOLITE/MC2 COILED BLACKHOSE ISOLITE/MC2 SWIVEL BLACKHOSE ISOLITE/MC2 SWIVEL GREYHOSE ISOLITE/MC2 SWIVEL WHITEHOSE ISOLITE/MC2 WHITEHOSE LIGHT MOTORHOSE MC E BLACKHOSE MC MEDICAMATHOSE MC2 GREYHOSE MC2 LE T GREYHOSE MCX GREYHOSE MCX GREY 2.2mHOSE MCX GREY 20.2x40HOSE MCX GREY 400 20.2x40HOSE MCX GREY ADECHOSE MCX OSSTEMHOSE MX2 400 GREYHOSE MX2 400 GREY 20.2x40HOSE MX2 400 PLANMECAHOSE MX2 400 SURF 6HOSE MX2 GREYHOSE SCALER POWERCAREHOSE T LE WHITEI-SURGE LEDLIGHT MOTORLUBRICARE MAINTENANCE SYSTEMLUBRICARE MAINTENANCE SYSTEM 2LUBRIFLUIDLUBRIMEDMC MX2MOT AQUILONMOT AQUILON830 IR NCMOT AQUILON830 SRMOT BASCHMOT ISOLITEMOT ISOLITE (LED)MOT ISOLITE LIMOT ISOLITE LKMOT MC2MOT MC2 40 GT IRMOT MC2 GT AVMOT MC2 IRMOT MC2 SRMOT MC3MOT MC3 (LED)MOT MC3 IRMOT MC3 LKMOT MCXMOT MCX LEDMOT MCX LED OSSTEM (EIL)MOT MXMOT MX CHIROPROMOT MX-iMOT MX-i LEDMOT MX-I LED NBMOT MX2PMPM 1:1PM 1:1 EXT SPRAYPM 1:1 EXT SPRAY LARESPM 1:1 MICRO-SERIESPM 1:2PM 10:1 PROPHYPM CA 1:1 L S-NXCPM CA 1:5L NOVA MSPM CA 20:1 L RO 104936PM HP 1:1 sp. ext. | 2008 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | AQUACARECA 20:1CA 20:1 LCA 20:1 l MICRO SERIESCA 20:1 L MICRO-SERIESCABLE MX LED 3MCABLE MX-i LEDCABLE MX-i LED 3RD GENCABLE MX-LEDChiropro 980 4 Buttons Foot Control 56 moreCONSOLE CHIROPROCONSOLE CHIROPRO 3RD GENCONSOLE CHIROPRO LCONSOLE CHIROPRO L PREMIUMCONSOLE CHIROPRO L PREMIUM USCONSOLE CHIROPRO L USCONSOLE CHIROPRO PLUS 3RD GENCONSOLE iCHIROPROCONSOLE iCHIROPRO SURGERYCONSOLE OMSCONSOLE OSSEOCARECONSOLE OSSEOCARE PROCONSOLE OSSEOCARE USCONSOLE PROIMPLANTCONSOLE PROIMPLANT 3RD GENFOOTCTRLFOOTCTRL CHIROPRO980MOT MX-iMOT MX-i LEDMOT MX-i LED 3RD GENMOT MX-LEDMOT MXi-LEDSET CHIROPROSET CHIROPRO + CA 20:1SET CHIROPRO 3RD GENSET CHIROPRO 3RD GEN CA 20:1LSET CHIROPRO 3RD GEN KMSET CHIROPRO 3RD GEN KM CASET CHIROPRO CA 20:1 LSET CHIROPRO LSET CHIROPRO L + CA 20:1 LSET CHIROPRO L CA 20:1SET CHIROPRO L PREMIUMSET CHIROPRO L PREMIUM CA 20:1 LSET CHIROPRO L USSET CHIROPRO L US CA 20:1 LSET CHIROPRO L US PM HP 1:2SET CHIROPRO L US PREMIUMSET CHIROPRO+ 3RD GEN CA 20:1 LSET CHIROPRO+ CA 20:1 LSET iCHIROPROSET iCHIROPRO + CA 20:1 L MSSET iCHIROPRO CA 20:1 L MS KMSET iCHIROPRO KMSET iCHIROPRO SURGERYSET iCHIROPRO SURGERY USSET iCHIROPRO SURGERY US PM HP 1:2SET OMSSET OSSEOCARESET OSSEOCARE CA 20:1 L MS NBSET OSSEOCARE PROSET OSSEOCARE USSET OSSEOCARE US CA 20:1 L MSSET PROIMPLANTSET PROIMPLANT 3RD GEN CA 20:1SET PROIMPLANT 3RD GEN CA 20:1 L | 2010 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | AP OPTIMA MCXBOARD DMCXBOARD DMXBOARD DMX BASICBOARD DMX BELMONTBOARD DMX DIGIPADBOARD DMX PROBOARD DMX SBOARD DMX-iBOARD DMX2 44 moreBOARD DMX2 PLUSBOARD DMX2 PROBoard DMX3BOARD DMX3 FULL OPENBOARD DMX3 iOPTIMA INT BOXBOARD DMX3 M BornierBOARD DMX3 M BtoBBOARD FO890BOARD iCHIROPROBOARD iOPTIMABOARD MPPE021 FOCONSOLE iOPTIMACONSOLE iOPTIMA INT 1x MX2CONSOLE iOPTIMA INT 2x MX2CONSOLE iOPTIMA INT MX2 MX-iCONSOLE OPTIMA INTCONSOLE OPTIMA MCXCONSOLE OPTIMA MXCONSOLE OPTIMA MX INTCONSOLE OPTIMA MX2 INTCONSOLE OPTIMA MX2 INT DMX3 CLCONSOLE OPTIMA MX2 INT PRO CLCONSOLE OPTIMA MX2 WHITE EDUCONSOLE OPTIMA MX2-EHose MX2 400 GREY 102646IDUP BoardKIT OPTIMA INTKIT OPTIMA MX2 INTNGO motor driverOPTIMA MCX INT DMCX 1 MOTOROPTIMA MCX INT DMX3 1 MOTOROPTIMA MX2 INT DMX3 1 MOTOROPTIMA MX2 INT DMX3 2 MOTORSOPTIMA MX2 INT PRO 2 MOTORSSET iOPTIMA INT 1x MX2 FULLSET iOPTIMA INT 1x MX2 LIGHTSET iOPTIMA INT 2x MX2 FULLSET iOPTIMA INT 2x MX2 LIGHTSET iOPTIMA INT MX2 MX-i FULLSET iOPTIMA INT MX2 MX-i LIGHTSET OPTIMA INTSET OPTIMA MX2 EDUCATIONAL 6SET OPTIMA MX2 INTSET OPTIMA MX2 PRO INT | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Bien-Air Dental, SA as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Dec 2009 | K092214 | CHIROPRO L SYSTEM | EBW Handpiece and Cord Foot Controller |
Some of these clearances are listed with FDA today by another company: Nobel Biocare Services AG (1).
Also lists devices cleared under other names
Bien-Air Dental, SA lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: J. Morita USA, Inc. (2), Bien-Air SA Switzerland (1), Bien Air USA, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Mar 2020 | K190509 | Lubrina 2 | J. Morita USA, Inc. | EFB Dental Air-Powered Handpiece |
| 31 May 2007 | K070074 | LUBRINA, MODEL HIM-1 | J. Morita USA, Inc. | EFB Dental Air-Powered Handpiece |
| 20 Oct 2004 | K042759 | OPTIMA MX | Bien-Air SA Switzerland | EIA Operative Dental Unit |
| 10 Dec 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | Bien Air USA, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Bien-Air Dental SAFDA reg. 3003268570 | Le Noirmont Jura, Switzerland | Contract manufacturer |
| BIEN-AIR DENTAL SAFDA reg. 9614446 | Biel/Bienne Bern, Switzerland | Foreign exporter, Manufacturer |
| Bien-Air Portugal Unipessoal LDAFDA reg. 3013576763 | Maia Porto, Portugal | Contract manufacturer, Manufacturer |
Other names on FDA records
Bien-Air Portugal Unipessoal LDA
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9034059). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.