FDA device listing
SKY DENT - 1DERFUL: HEDSTROM, K-FILE, C-FILE, GO, BRAVO, CHALLENGER, NU, DUO, DISCOVERY, RE-DO.
FDA device listing 1624068255 · SKY DENT Corp for dental trading
Key facts
| Proprietary names | SKY DENT - 1DERFUL: HEDSTROM, K-FILE, C-FILE, GO, BRAVO, CHALLENGER, NU, DUO, DISCOVERY, RE-DO. |
|---|---|
| Owner/operator | SKY DENT Corp for dental trading |
| Owner/operator number | 10050378 |
| Product codes | EKS |
| Device names | EKS - File, Pulp Canal, Endodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | SKY DENT Corp for dental trading |
| Establishment registrations | 3012101632 |
| FEI numbers | 3012101632 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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