FDA device listing
PNUADD Standard Surgical KIT_Depth Gaouge, Torque Wrench,PNUADD Standard Surgical KIT_Lance Drill, Stright Stopper…
FDA device listing 1599218427 · PNUAdd Co., Ltd.
Key facts
| Proprietary names | PNUADD Standard Surgical KIT_Depth Gaouge, Torque Wrench,PNUADD Standard Surgical KIT_Lance Drill, Stright Stopper Drill, Final Stopper Drill;,PNUADD Standard Surgical KIT_Parallel Pin, Fixture Driver, Hex Driver, Drill Stopper;,PNUADD Taper Surgical KIT_ Fixture Driver, Depth Gauge, Torque Ratchet;,PNUADD Taper Surgical KIT_ Lance Drill, Lindemann Drill, Drill Extension, Straight Drill, Taper… |
|---|---|
| Owner/operator | PNUAdd Co., Ltd. |
| Owner/operator number | 10089089 |
| Product codes | NDP |
| Device names | NDP - Accessories, Implant, Dental, Endosseous |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3980 |
| Review panels | Dental |
| Registered establishments | PNUAdd Co., Ltd. |
| Establishment registrations | 3029973772 |
| FEI numbers | 3029973772 |
| 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