FDA device listing
Dental Implant Surgical Tray,Surgical Kit full, Mini Surgical Kit, Stainless Steel Surgical Tube, Integral Stopper Kit
FDA device listing 2011826578 · Ditron Dental Ltd
Key facts
| Proprietary names | Dental Implant Surgical Tray,Surgical Kit full, Mini Surgical Kit, Stainless Steel Surgical Tube, Integral Stopper Kit |
|---|---|
| Owner/operator | Ditron Dental Ltd |
| Owner/operator number | 10049877 |
| Product codes | OFY |
| Device names | OFY - Dental Implant Surgical Tray |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3980 |
| Review panels | Dental |
| Registered establishments | DITRON DENTAL LTD |
| Establishment registrations | 3010948854 |
| FEI numbers | 3010948854 |
| 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