FDA device listing
dental splints
FDA device listing 1341028906 · Debo Medical Technology (Shijiazhuang) Co., Ltd.
Key facts
| Proprietary names | dental splints |
|---|---|
| Owner/operator | Debo Medical Technology (Shijiazhuang) Co., Ltd. |
| Owner/operator number | 10094976 |
| Product codes | HSP |
| Device names | HSP - Splint, Traction |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.5890 |
| Review panels | Orthopedic |
| Registered establishments | DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD. |
| Establishment registrations | 3043648115 |
| FEI numbers | 3043648115 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Foreign Private Label Distributor, 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