FDA device listing
Barbed Broach,Hedstrom Files,K3 Files,K3XF Files,K-Files,K-Flex Files,LA Axxess,LightSpeed CRX,LightSpeed…
FDA device listing 1094649693 · SYBRON DENTAL SPECIALTIES, INC.
Key facts
| Proprietary names | Barbed Broach,Hedstrom Files,K3 Files,K3XF Files,K-Files,K-Flex Files,LA Axxess,LightSpeed CRX,LightSpeed LSX,Pathfinder,Pathfinder CS,Quantec Axxess Files,Quantec Files,Retreatment Files,Root Canal Reamers,TF Adaptive Files,TF (Twisted Files),Traverse Files,Traverse Glide Path File,Traverse Orifice and Glide Path File,Traverse Orifice Opener,Triple Flex Files,ZenFlex Files,ZenFlex One Sterile and… |
|---|---|
| Owner/operator | SYBRON DENTAL SPECIALTIES, INC. |
| Owner/operator number | 9029565 |
| 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 | Kerr Corporation, Kerr Italia, S.r.l., Ormex S. de R.L. de C.V. |
| Establishment registrations | 8020994, 8030637, 3012477813 |
| FEI numbers | 1000231788, 3002807826, 3012477813 |
| Establishment operations | Contract Manufacturer, 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