FDA device listing
COMFY SPLINTS,PRODUCTS
FDA device listing 1405603938 · LENJOY MEDICAL ENGINEERING, INC.
Key facts
| Proprietary names | COMFY SPLINTS,PRODUCTS |
|---|---|
| Owner/operator | LENJOY MEDICAL ENGINEERING, INC. |
| Owner/operator number | 2025918 |
| Product codes | EBL |
| Device names | EBL - Pin, Retentive And Splinting, And Accessory Instruments |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3740 |
| Review panels | Dental |
| Registered establishments | LENJOY MEDICAL ENGINEERING, INC. |
| Establishment registrations | 2025918 |
| FEI numbers | 2025918 |
| 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