# Bien Air USA, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 2 (1998–1999): 2 510(k) clearances
- Product codes: EFB (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kavo America: 1 (https://510kreport.com/company/kavo-america)
- Jedmed Instrument Co.: 1 (https://510kreport.com/company/jedmed-instrument)

## Firms that cite its devices most
- Lares Research, Inc.: 2 (https://510kreport.com/company/lares-research)
- Sable Industries, Inc.: 2 (https://510kreport.com/company/sable-industries)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)

## Its most-cited devices
- K983183: Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P (1998), cited by 4
- K984244: Orl-E-92 Surgical Drill System (1999), cited by 1

## Recent decisions
- K984244: Orl-E-92 Surgical Drill System (Feb 23, 1999)
- K983183: Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P (Dec 10, 1998)

Source page: https://510kreport.com/company/bien-air-usa