FDA device listing
Dental implant "Zahntium Implant",IAB +3.3x10 Implant Active Bio Plus 0 3.3 L 10,IAB +3.3x11.5 Implant Active Bio Plus 0…
FDA device listing 1512999538 · Alpha Dent Implants GmbH
Key facts
| Proprietary names | Dental implant "Zahntium Implant",IAB +3.3x10 Implant Active Bio Plus 0 3.3 L 10,IAB +3.3x11.5 Implant Active Bio Plus 0 3.3 L 11.5,IAB +3.3x13 Implant Active Bio Plus 0 3.3 L 13,IAB +3.3x8 Implant Active Bio Plus 0 3.3 L 8,IAB +3.75x10 Implant Active Bio Plus 0 3.75 L 10,IAB +3.75x11.5 Implant Active Bio Plus 0 3.75 L 11.5,IAB +3.75x13 Implant Active Bio Plus 0 3.75 L 13,IAB +3.75x16 Implant… |
|---|---|
| Owner/operator | Alpha Dent Implants GmbH |
| Owner/operator number | 10086730 |
| Premarket submissions | K180968 |
| Product codes | DZE |
| Device names | DZE - Implant, Endosseous, Root-Form |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3640 |
| Review panels | Dental |
| Registered establishments | ALPHA DENT IMPLANTS GMBH |
| Establishment registrations | 3015383403 |
| FEI numbers | 3015383403 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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