Data / Medical devices / Portugal / Bien-Air Portugal Unipessoal LDA
Bien-Air Portugal Unipessoal LDA: FDA-registered device maker in Maia Porto, Portugal, 1 510(k) clearance
Bien-Air Portugal Unipessoal LDA is registered with the FDA (registration 3013576763) in Maia Porto, Portugal. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 10, 1998. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013576763
- Address
- Rua de Jose Francisco da Conceicao, n141, PT, Maia Porto, Portugal, 4470-044
- Owner or operator
- BIEN-AIR DENTAL SA (9034059)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 17, 2008
- Registered through
- 2026
- Brand names listed
- ADAPTER, AQUACARE, BUR GUARD HP 1:2 (100 PCES), CA, CA 10:1, CA 10:1 L, CA 15:1 PROPHY, CA 1:1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Controller, Foot, Handpiece And Cord | EBW | 1 | Contract manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 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 |
|---|---|---|---|---|---|---|
| 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 |
Compare with other makers
Updated December 10, 1998. 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.