Facility

Bien-Air Portugal Unipessoal LDA

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)	3013576763
Establishment type	Manufacture Medical Device
Location	Rua de Jose Francisco da Conceicao, n141, PT Maia Porto, PT 44700
Registration status	Active · expires 2026
Parent company	BIEN-AIR DENTAL SA (owner-operator 9034059)
Brand names	CA Midwest® lmplant 20:1 L; MOT MCX LED OSSTEM (EIL); smartIPR; CA 8:1; LUBRIMED; CA; HOSE; CA EVO; AQUACARE; PM; TUR BORALINA; TUR BORA

Activity by year

Recalls (1)

Devices registered here (1)

Handpiece, Air-Powered, Dental
Product code EFB (opens in a new tab) · Class I · Dental · 21 CFR 872.4200

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 Portugal Unipessoal LDA (FEI 3013576763) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013576763-bien-air-portugal-unipessoal-lda/

Not open yet

Alerts for Bien-Air Portugal Unipessoal LDA

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.