Alpha Dent Implants GmbH
DE-MF-000007046 · Germany · Pforzheim
Alpha Dent Implants GmbH is registered in the European database on medical devices as a manufacturer, with 120 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 120 |
|---|
Most frequent device types declared: Sterility Dental Implant Active Konus, ZIA Implant, Sterility Dental Implant Slim, Sterility Dental Implant Superior Active.
Among these devices, 120 are declared sterile, 120 implantable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ALPHA DENT IMPLANTS GMBH (DE) · FDA 3015383403 |
| Devices in EUDAMED | 120 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
26 0085 QR/NB | issued | 2031-03-15 |
25 0445 QR/NB | issued | 2030-11-20 |