FDA device listing
Cortical Drill,Countersink Drill,Drill Extension,Guided Surgery Drill,Pterygoid Implants Drill,Step Drill,Trephine…
FDA device listing 1425542231 · Bioline Dental Implant Systems Ltd
Key facts
| Proprietary names | Cortical Drill,Countersink Drill,Drill Extension,Guided Surgery Drill,Pterygoid Implants Drill,Step Drill,Trephine Drill,Zygomatic Implants Drill |
|---|---|
| Owner/operator | Bioline Dental Implant Systems Ltd |
| Owner/operator number | 10092547 |
| Product codes | QRQ |
| Device names | QRQ - Non-Irrigation Endosseous Dental Implant Drill Bits |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3980 |
| Review panels | Dental |
| Registered establishments | BIOLINE DENTAL IMPLANT SYSTEMS LTD |
| Establishment registrations | 3014329459 |
| FEI numbers | 3014329459 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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