510(k) Report

FDA applicant

Bien-Air SA Switzerland

Bienne 6, CH1 decision2004–20040 recalls

FDA records 1 decision for Bien-Air SA Switzerland (Bienne 6, CH) in 2004: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Bien-Air SA Switzerland’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bien-Air SA Switzerland since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bien-Air SA Switzerland by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EIAUnit, Operative Dental1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042759Optima MXBien-Air SA Switzerland · 20045cite it

What has FDA decided for it lately?

  • K042759Optima MXBien-Air SA Switzerland · 2004

The one decision as Bien-Air SA Switzerland →

Other applicant names beginning “Bien-Air”

FDA records each applicant name separately; these may or may not be the same firm.

Bien-Air Surgery SA 5Bien Air USA, Inc. 2Bien-Air Dental, SA 1