Medical Device Manufacturer · US , Irvine , CA

Bien Air USA, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1998

Recent clearances: ORL-E-92 SURGICAL DRILL SYSTEM, GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bien Air USA, Inc. Dental ✕

2 devices

1-2 of 2

Cleared Feb 23, 1999

ORL-E-92 SURGICAL DRILL SYSTEM

Cleared Dec 10, 1998

GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON,...