Not currently registered with FDA under this name
Bien Air USA, Inc.
San Diego, CA, United States. Named as applicant on 2 dental 510(k) clearances between 1998 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 21998–1999
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Bien Air USA, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Feb 1999 | K984244 | ORL-E-92 SURGICAL DRILL SYSTEM | EFB Dental Air-Powered Handpiece |
| 10 Dec 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | EFB Dental Air-Powered Handpiece |
Some of these clearances are listed with FDA today by another company: A-dec, Inc. (1), Dentsply Sirona, Inc. (1), Nobel Biocare Services AG (1), Bien-Air Dental, SA (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.