FDA device listing
100350 SmartPeg Type 4,100353 SmartPeg Type 1,100355 SmartPeg Type 2,100357 SmartPeg Type 3,100359 SmartPeg Type…
FDA device listing 1433555347 · SWANN MORTON, LTD.
Key facts
| Proprietary names | 100350 SmartPeg Type 4,100353 SmartPeg Type 1,100355 SmartPeg Type 2,100357 SmartPeg Type 3,100359 SmartPeg Type 12,100361 SmartPeg Type 13,100363 SmartPeg Type A3,100366 SmartPeg Type 8,100368 SmartPeg Type 9,100370 SmartPeg Type 10,100372 SmartPeg Type 11,100374 SmartPeg Type 14,100376 SmartPeg Type 5,100378 SmartPeg Type 6,100380 SmartPeg Type 7,100386 SmartPeg Type 15,100388 SmartPeg Type… |
|---|---|
| Owner/operator | SWANN MORTON, LTD. |
| Owner/operator number | 9003320 |
| Product codes | EKX |
| Device names | EKX - Handpiece, Direct Drive, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | Swann-Morton(Services) Limited |
| Establishment registrations | 3008812251 |
| FEI numbers | 3002808293 |
| Establishment operations | Contract Sterilizer |
| 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