Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614446

FEI Number

3002762033

Entity Name

BIEN-AIR DENTAL SA

City/State/Country

Biel/Bienne Bern, CH

Establishment Address

LANGGASSE 60, Biel/Bienne Bern 2504, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

BIEN-AIR DENTAL SA (Owner Number: 9034059)

Owner / Operator Contact Address

Langgasse 60, --, BIENNE, CH-BE 2504, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070074

PMA Number

N/A

All Registered Proprietary Names

iOptima APP iChiropro Surgery APP iChiropro APP Catheter for irrigation, Irrigation line Sterile Protection Chiropro Sterile Protection Sheet Catheter for Irrigation, Irrigation Line IRRIGATION LINE IRRIGATION LINE KM IRRIG. LINE CHIROPRO L 3.5M LUBRICARE MAINTENANCE SYSTEM 2 PM OSCILLATING IPR CABLE SPRAYNET TUR PRESTIGE TUR BORALINA CA EVO TUR GYRO CA TUR BLACK PEARL ADAPTER HOSE AQUACARE TUR BORA LUBRIFLUID TUR PRESTILINA TUR TORNADO LUBRIMED TUR EOLIA PM TUR TORNADO S TUR TORNADO X CA ENDO CA 10:1 L PM 1:1 EXT SPRAY LARES CA 10:1 HOSE 4 HOLE L SURF6 MIDWEST CA 1:5 L MICRO-SERIES TUR PRESTIGE LK BLACKLINE MOT MC3 IR CA 1:1 EXT SPRAY WELDED HOSE 4VLM10 BLACK CA 1:1 L HOSE 4 HOLE L BLACK MIDWEST HOSE B-MX2 GREY MOT MC2 GT AV HOSE 4VLM11 BLACK HOSE 4VLM GREY MOT MC2 IR MOT MC3 LK MOT ISOLITE LI COUPLING UNIFIX 4H L WATER ADJ CA 1:1 L MICRO-SERIES HOSE MCX GREY TUR PRESTIGE LK HOSE 4VLM11 GREY TUR BORA L MOT ISOLITE LK HOSE 4VR400 GREY TUR BLACK PEARL 4H B CARE HOSE ISOLITE/MC2 SWIVEL WHITE CA 30:1 EXT SPRAY WELDED PRESTIGE - 5 HOLE W/O COUPLER COUPLING UNIFIX 4H US TUR BORA LK BLACKLINE PM PROLAB HOSE B-4VR 400 GREY L 1700 PM 1:1 EXT SPRAY COUPLING UNIFIX 3H HOSE 4VLM11 SURF6 ADEC CA 1:1 L LARES COUPLING EOLIA B 4H HOSE ISOLITE WATER ADJ GREY HOSE MCX GREY 400 20.2x40 MOT MC3 (LED) CA 20:1 L KM MICRO-SERIES SET STUDENTS BAUSA 7 CA ENDO + ACTIVATION CODE CA 1:2.5 L MS CA 1:5 L MICRO-SERIES LARES CA 20:1 L KM BUR GUARD HP 1:2 (100 PCES) HOSE MX2 400 GREY 20.2x40 COUPLING UNIFIX® 4VL Midwest MOT MX-i LED CA 1:1 L EVO15 TUR PRESTIGE L BLACKLINE LED COUPLING SOCKET B CA 30:1 EXT SPRAY HOSE ISOLITE/MC2 COILED BLACK CA 1:5 TUR TORNADO X LED TUR BORA L LED CA 15:1 PROPHY MOT AQUILON830 SR HOSE MCX GREY ADEC PM 1:1 MICRO-SERIES UPGRADE KIT BUR GUARD HP 1:2 HOSE MC E BLACK TUR BORA L BLACKLINE MOT MCX LED CA 1:1 L MICRO-SERIES LARES TUR PRESTIGE L LED CA 1:1 L EVO15 MICRO-SERIES CA NOVA 1:1L MOT MX-I LED NB HOSE ISOLITE/MC2 WHITE HOSE 5 HOLE L GREY MIDWEST HOSE MCX GREY 20.2x40 CA 1:5 L EVO15 HOSE SCALER POWERCARE HOSE 4VR400 SURF6 ADEC MOT MX CHIROPRO HOSE MC2 LE T GREY HOSE 4VR400 GREY MIDWEST CA 1:5 L LARES CA 1:1 HOSE 4 HOLE L M 10 GREY B COUPLING MULTIFLEX® 4H L TUR TORNADO LED HOSE MX2 GREY TUR BORA LK MOT AQUILON830 IR NC TUR BLACK PEARL ECO 3H MOT MC2 40 GT IR HOSE MX2 400 PLANMECA CA 20:1 CA 1:5 L EVO15 MICRO-SERIES COUPLING SOCKET B 4B-VX TUR TORNADO X LK CA NOVA 1:1L MS COUPLING SOCKET B B-MX2 SET STUDENTS BAUSA 5 HOSE 6 HOLE L GREY MIDWEST HOSE 4VX GREY HOSE MC2 GREY PM 1:2 HOSE ISOLITE/MC2 BLACK SET STUDENTS BAUSA 6 COUPLING UNIFIX 4H L CA 1:1 EXT SPRAY HOSE T LE WHITE CA 20:1 L MICRO-SERIES PM 10:1 PROPHY CA 1:5 L HOSE MX2 400 GREY PM 1:1 COUPL MULTIFLEX® 4HL WATER ADJ CA 20:1 L HOSE B-4VR400 GREY CA NOVA 1:5L MOT ISOLITE (LED) HOSE MC MEDICAMAT TUR PRESTIGE L HOSE B-4VX GREY MOT MC2 HOSE B-MCX GREY HOSE 4VX SURF6 ADEC TUR TORNADO S LK COUPLING UNIFIX 4H HOSE ISOLITE/MC2 SWIVEL BLACK TUR TORNADO S LED HOSE MCX GREY 2.2m CA NOVA 1:5L MS TUR TORNADO LK HOSE MX2 400 SURF 6 HOSE ISOLITE/MC2 SWIVEL GREY MOT MC2 SR SET STUDENTS BAUSA 4 MOT ISOLITE MOT BASCH TU Bora 2 LK MOT MC3 MOT MX-i MOT AQUILON COUPLING TU Bora 2 LED MOT MCX MOT MX2 MOT MX SET STUDENTS BAUSA 14 PM HP 1:1 sp. ext. PM CA 1:1 L S-NXC XPU MMOTOR LIGHT CABLE I-SURGE LED SET STUDENTS BAUSA 13 I-SURGE LED PM CA 20:1 L RO 104936 LIGHT MOTOR PM CA 1:5L NOVA MS CA PRIMA 1:1 L MS SET STUDENTS BAUSA 8 MC MX2 CA PRIMA 1:1 L CA PRIMA 1:1 CA Midwest® lmplant 20:1 L CA 1:2.5 L HOSE LIGHT MOTOR XPU MMOTOR CABLE PM PM 1:1 RO sp. ext. 104936 TY MX2 400° calotte 20.2x40 smartIPR XPU MMOTOR NO LIGHT CA 8:1 CA PRIMA 1:121 BOARD DMX3 M Bornier BOARD DMX3 M BtoB CONSOLE iOPTIMA CONSOLE OPTIMA MX2-E Board DMX3 CONSOLE OPTIMA MCX CONSOLE OPTIMA INT CONSOLE iOPTIMA INT 1x MX2 SET OPTIMA MX2 PRO INT KIT OPTIMA MX2 INT SET OPTIMA MX2 INT KIT OPTIMA INT BOARD DMX3 iOPTIMA INT BOX SET iOPTIMA INT MX2 MX-i FULL SET iOPTIMA INT 1x MX2 LIGHT SET iOPTIMA INT 1x MX2 FULL BOARD DMX DIGIPAD CONSOLE iOPTIMA INT 2x MX2 SET iOPTIMA INT 2x MX2 FULL AP OPTIMA MCX CONSOLE OPTIMA MX2 INT DMX3 CL CONSOLE iOPTIMA INT MX2 MX-i SET iOPTIMA INT MX2 MX-i LIGHT OPTIMA MX2 INT DMX3 1 MOTOR CONSOLE OPTIMA MX2 WHITE EDU BOARD FO890 BOARD iOPTIMA SET OPTIMA INT BOARD DMX S BOARD DMX2 PRO CONSOLE OPTIMA MX2 INT PRO CL BOARD DMX BELMONT BOARD DMX3 FULL OPEN BOARD MPPE021 FO OPTIMA MX2 INT DMX3 2 MOTORS BOARD iCHIROPRO OPTIMA MCX INT DMX3 1 MOTOR OPTIMA MCX INT DMCX 1 MOTOR SET iOPTIMA INT 2x MX2 LIGHT BOARD DMX2 CONSOLE OPTIMA MX2 INT CONSOLE OPTIMA MX CONSOLE OPTIMA MX INT OPTIMA MX2 INT PRO 2 MOTORS BOARD DMX BOARD DMX BASIC BOARD DMCX BOARD DMX PRO BOARD DMX-i BOARD DMX2 PLUS IDUP Board NGO motor driver SET OPTIMA MX2 EDUCATIONAL 6 Bur Guard SET OSSEOCARE US CA 20:1 L MS SET CHIROPRO L CA 20:1 SET CHIROPRO CA 20:1 L SET CHIROPRO L CA 20:1 l MICRO SERIES SET CHIROPRO L PREMIUM CA 20:1 L CONSOLE CHIROPRO PLUS 3RD GEN SET CHIROPRO L US PM HP 1:2 SET CHIROPRO L US CA 20:1 L SET iCHIROPRO SURGERY US CONSOLE CHIROPRO L US CONSOLE CHIROPRO SET iCHIROPRO CA 20:1 L MS KM MOT MXi-LED SET CHIROPRO L US CONSOLE CHIROPRO L PREMIUM SET CHIROPRO CA 20:1 L SET OSSEOCARE US SET CHIROPRO+ CA 20:1 L SET iCHIROPRO + CA 20:1 L MS SET CHIROPRO + CA 20:1 SET iCHIROPRO SURGERY US PM HP 1:2 SET PROIMPLANT SET CHIROPRO L + CA 20:1 L CONSOLE CHIROPRO 3RD GEN SET iCHIROPRO KM CONSOLE OSSEOCARE US SET OSSEOCARE CA 20:1 L MS NB AQUACARE CONSOLE CHIROPRO L PREMIUM US SET CHIROPRO 3RD GEN CA 20:1L SET CHIROPRO L PREMIUM CONSOLE PROIMPLANT SET CHIROPRO 3RD GEN KM CA CA 20:1 FOOTCTRL CHIROPRO980 SET PROIMPLANT 3RD GEN CA 20:1 SET CHIROPRO 3RD GEN SET CHIROPRO 3RD GEN KM SET PROIMPLANT 3RD GEN CA 20:1 L SET OMS CABLE MX LED 3M MOT MX-i LED 3RD GEN CONSOLE OMS CABLE MX-i LED 3RD GEN CONSOLE PROIMPLANT 3RD GEN Chiropro 980 4 Buttons Foot Control CONSOLE CHIROPRO L FOOTCTRL CONSOLE iCHIROPRO CONSOLE OSSEOCARE SET CHIROPRO L US PREMIUM CONSOLE iCHIROPRO SURGERY MOT MX-i LED CA 20:1 L MICRO-SERIES MOT MX-LED SET iCHIROPRO CABLE MX-LED CONSOLE OSSEOCARE PRO SET iCHIROPRO SURGERY SET OSSEOCARE SET OSSEOCARE PRO CABLE MX-i LED MOT MX-i SET CHIROPRO+ 3RD GEN CA 20:1 L SET iOPTIMA INT 1x MX2 FULL SET iOPTIMA INT 2x MX2 FULL SET iOPTIMA INT 2x MX2 LIGHT SET iOPTIMA INT MX2 + MXi FULL CONSOLE iOPTIMA INT 2x MX2 CONSOLE iOPT. INT MX2 MX-i SET iOPTIMA INT MX2 + MXi LIGHT CONSOLE iOPTIMA INT 1x MX2 SET iOPTIMA INT 1x MX2 LIGHT Oscillating Microsaw LONG MICROSAW BLADE SHORT MICROSAW BLADE RECIPROCATING MICROSAW PM 1:1 TWIST DRILL Sagittal Microsaw LUBRICARE MAINTENANCE SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-12-03
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2011-12-01
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2020-12-17
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-11-17
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-12-21
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-09-09
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2010-01-11
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2021-02-11
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2021-01-21
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2013-06-13

Official Correspondent

Carine Beriet

US Agent Details

ARTHUR MATEEN Business: BIEN AIR USA, INC. Email: arthur.mateen@bienair.com Phone: (949) 4776050

Related Public Records

Same Entity

BIEN-AIR DENTAL SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013576763	Bien-Air Portugal Unipessoal LDA	Maia Porto, PT
3003268570	Bien-Air Dental SA	Le Noirmont Jura, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614446. Last updated year: 2026. Please use registration number 9614446 when referencing this establishment in official correspondence.