Data / Medical devices / Switzerland / Bien-Air Dental SA

Bien-Air Dental SA: FDA-registered device maker in Biel/Bienne Bern, Switzerland, 5 510(k) clearances

Name: Bien-Air Dental SA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bien-Air Dental SA is registered with the FDA (registration 9614446) in Biel/Bienne Bern, Switzerland. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 4, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Bien-Air Dental SA

FDA registration number: 9614446
FEI number: 3002762033
Address: Langgasse 60, Biel/Bienne Bern, Switzerland, 2504
Owner or operator: BIEN-AIR DENTAL SA (9034059)
Roles: Exporter to the US, Manufacturer
First device listed: December 21, 2007
Registered through: 2026
Brand names listed: ADAPTER, AP OPTIMA MCX, AQUACARE, BOARD DMCX, BOARD DMX, BOARD DMX BASIC, BOARD DMX BELMONT, BOARD DMX DIGIPAD and more

Devices it lists

Device	Product code	Class	Role	Source
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Exporter to the US	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Exporter to the US	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 4, 2020	K190509	Lubrina 2	EFB	Substantially Equivalent	J. Morita USA, Inc.	accessdata.fda.gov
December 15, 2009	K092214	CHIROPRO L SYSTEM	EBW	Substantially Equivalent	Bien-Air Dental, SA	accessdata.fda.gov
May 31, 2007	K070074	LUBRINA, MODEL HIM-1	EFB	Substantially Equivalent	J. Morita USA, Inc.	accessdata.fda.gov
October 20, 2004	K042759	OPTIMA MX	EIA	Substantially Equivalent	Bien-Air SA Switzerland	accessdata.fda.gov
December 10, 1998	K983183	GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P	EFB	Substantially Equivalent	Bien Air USA, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 27, 2015	72079	Class II	Terminated	Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures	Possible loosening of the dental tool, which may lead to potential swallowing of the tool.	accessdata.fda.gov

Compare with other makers

Updated March 4, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.