FDA device listing
ADAPTER,AQUACARE,BUR GUARD HP 1:2 (100 PCES),CA,CA 10:1,CA 10:1 L,CA 1:1,CA 1:1 EXT SPRAY,CA 1:1 EXT SPRAY WELDED,CA 1:1…
FDA device listing 1998235611 · BIEN-AIR DENTAL SA
Key facts
| Proprietary names | ADAPTER,AQUACARE,BUR GUARD HP 1:2 (100 PCES),CA,CA 10:1,CA 10:1 L,CA 1:1,CA 1:1 EXT SPRAY,CA 1:1 EXT SPRAY WELDED,CA 1:1 L,CA 1:1 L EVO15,CA 1:1 L EVO15 MICRO-SERIES,CA 1:1 L LARES,CA 1:1 L MICRO-SERIES,CA 1:1 L MICRO-SERIES LARES,CA 1:2.5 L,CA 1:2.5 L MS,CA 1:5,CA 15:1 PROPHY,CA 1:5 L,CA 1:5 L EVO15,CA 1:5 L EVO15 MICRO-SERIES,CA 1:5 L LARES,CA 1:5 L MICRO-SERIES,CA 1:5 L MICRO-SERIES LARES,CA… |
|---|---|
| Owner/operator | BIEN-AIR DENTAL SA |
| Owner/operator number | 9034059 |
| Premarket submissions | K983183 |
| Product codes | EFB |
| Device names | EFB - Handpiece, Air-Powered, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | BIEN-AIR DENTAL SA, Bien-Air Portugal Unipessoal LDA |
| Establishment registrations | 9614446, 3013576763 |
| FEI numbers | 3002762033, 3013576763 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database