FDA device listing
Translux 2 Wave,TRANSLUX POWER BLUE,Translux Wave
FDA device listing 1441793523 · Kulzer, LLC
Key facts
| Proprietary names | Translux 2 Wave,TRANSLUX POWER BLUE,Translux Wave |
|---|---|
| Owner/operator | Kulzer, LLC |
| Owner/operator number | 9056636 |
| Premarket submissions | K042199 |
| Product codes | EBZ |
| Device names | EBZ - Activator, Ultraviolet, For Polymerization |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.6070 |
| Review panels | Dental |
| Registered establishments | KULZER GMBH |
| Establishment registrations | 3005665377 |
| FEI numbers | 3005665377 |
| Establishment operations | Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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