FDA device listing
Aquarius,Aquarius Ceramic Solder,Capricorn 15,d.SIGN 53,d.SIGN 59,d.SIGN 67,d.SIGN 91,Elektra,Evolution Lite,Harmony…
FDA device listing 1068067996 · IVOCLAR VIVADENT
Key facts
| Proprietary names | Aquarius,Aquarius Ceramic Solder,Capricorn 15,d.SIGN 53,d.SIGN 59,d.SIGN 67,d.SIGN 91,Elektra,Evolution Lite,Harmony 2,Harmony X-Hard,IS-64,Laser C&B White,Laser C&B Yellow,Lodestar,Magenta,Solarcast 20,Special High Fusing White Ceramic Solder,Super Solder Ceramic Solder,Universal Solder 1015 W,Universal Solder PKF,W-2,W-3 |
|---|---|
| Owner/operator | IVOCLAR VIVADENT |
| Owner/operator number | 8010208 |
| Product codes | EJS |
| Device names | EJS - Alloy, Other Noble Metal |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3060 |
| Review panels | Dental |
| Registered establishments | IVOCLAR VIVADENT, INC. |
| Establishment registrations | 1316092, 3009496224 |
| FEI numbers | 1316092, 3009496224 |
| Establishment operations | Foreign Exporter, 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