Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003268570

FEI Number

3003268570

Entity Name

Bien-Air Dental SA

City/State/Country

Le Noirmont Jura, CH

Establishment Address

Rue de l'Ouest 2b, Le Noirmont Jura 2340, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2010-01-11

Official Correspondent

No official correspondent registered.

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
9614446	BIEN-AIR DENTAL SA	Biel/Bienne Bern, CH
3013576763	Bien-Air Portugal Unipessoal LDA	Maia Porto, PT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21

Similar Registrations

Registration Number	Establishment Name	Location
3014683120	JMU DENTAL, INC	Fullerton, CA, US
2520265	DENTALEZ, INC., STARDENTAL DIVISION	Lancaster, PA, US
3009768364	Foshan CICADA Dental Instrument Co., Ltd.	Foshan Guangdong, CN
9611253	NAKANISHI INC.	Kanuma Tochigi, JP
1054713	TOYO MEDICAL CO.	Doral, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003268570. Last updated year: 2026. Please use registration number 3003268570 when referencing this establishment in official correspondence.