FDA device listing
2-line Non-Fiber Optic Swivel,430 Torque HP,4-line Non-Fiber Optic Swivel,5-Hole Fiber Optic Swivel,HiFlo Fiber Optic…
FDA device listing 1168341481 · DENTALEZ, INC.
Key facts
| Proprietary names | 2-line Non-Fiber Optic Swivel,430 Torque HP,4-line Non-Fiber Optic Swivel,5-Hole Fiber Optic Swivel,HiFlo Fiber Optic Swivel,LED Plug N Play Swivel Assembly,LED Swivel,Star 440 Flex Handpieces,Star 440 Handpiece |
|---|---|
| Owner/operator | DENTALEZ, INC. |
| Owner/operator number | 2513147 |
| Premarket submissions | K153411 |
| Product codes | EFB |
| Device names | EFB - Handpiece, Air-Powered, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | DENTALEZ, INC., STARDENTAL DIVISION |
| Establishment registrations | 2520265 |
| FEI numbers | 2520265 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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