Facility

BIEN-AIR DENTAL SA

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002762033
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	LANGGASSE 60 Biel/Bienne Bern, CH 2504
Registration status	Active · expires 2026
Parent company	BIEN-AIR DENTAL SA (owner-operator 9034059)
Brand names	Catheter for irrigation, Irrigation line; Sterile Protection Chiropro; Sterile Protection Sheet; Catheter for Irrigation, Irrigation Line; IRRIGATION LINE; IRRIG. LINE CHIROPRO L 3.5M; IRRIGATION LINE KM

Activity by year

Recalls (1)

Devices registered here (1)

Catheter, Irrigation
Product code GBX (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4200

Recalls & enforcement

Class IITerminated2015-08-27
Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BIEN-AIR DENTAL SA (FEI 3002762033) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002762033-bien-air-dental-sa/

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