Bien-Air Dental SA

Le Noirmont Jura, CH

BIEN-AIR DENTAL SA appears in FDA device records in Le Noirmont Jura, CH. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 2

510(k) clearance history

FDA records hold 1 510(k) clearance for Bien-Air Dental SA in 2009.

Clearances by year, as a table

510(k) clearance decisions for Bien-Air Dental SA, by decision year
Year	Clearances
2009	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K092214	CHIROPRO L SYSTEM	EBW	Substantially Equivalent	2009-12-15

Registered establishments

FDA registered establishments for Bien-Air Dental SA, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9614446	3002762033	BIEN-AIR DENTAL SA	LANGGASSE 60, Biel/Bienne Bern 2504 CH	2026	EBW EFB EIA FZX GBX GEY GFA OUG
3003268570	3003268570	Bien-Air Dental SA	Rue de l'Ouest 2b, Le Noirmont Jura 2340 CH	2026	EBW

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2797-2015	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.	Class II	2015-08-27	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain