FDA device listing
818-2131 Traverse Rotary Glide Path File -.06/.13/21mm - N,818-2132 Traverse Rotary Glide Path File -.06/.13/25mm…
FDA device listing 1332730061 · Life Science Outsourcing, Inc.
Key facts
| Proprietary names | 818-2131 Traverse Rotary Glide Path File - .06/.13/21mm - N,818-2132 Traverse Rotary Glide Path File - .06/.13/25mm - N,818-2133 Traverse Rotary Glide Path File - .06/.13/31mm - N,818-2141 Traverse Orifice and Glide Path File - .06/.13/21mm - N,818-2142 Traverse Orifice and Glide Path File - .06/.13/25mm - N,818-2143 Traverse Orifice and Glide Path File - .06/.13/31mm - N,818-2146 Traverse Orifice… |
|---|---|
| Owner/operator | Life Science Outsourcing, Inc. |
| Owner/operator number | 10024857 |
| 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 | LIFE SCIENCE OUTSOURCING, INC. |
| Establishment registrations | 2031093 |
| FEI numbers | 3001236549 |
| Establishment operations | Contract Manufacturer, 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