FDA applicant

Bien Air USA, Inc.

Irvine, CA2 decisions1998–19990 recalls

FDA records 2 decisions for Bien Air USA, Inc. (Irvine, CA) from 1998 to 1999: 2 510(k) clearances. All are in product code EFB (Handpiece, Air-Powered, Dental). Its devices cite 2 predicates, 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 USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bien Air USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bien Air USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Bien”

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

Bien-Air Surgery SA 5 Bien-Air SA Switzerland 1 Bien-Air Dental, SA 1

Bien Air USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bien”