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, Sterility Dental Implant Slim, Sterility Dental Implant Superior Active, ZIA Implant.
Among these devices, 120 are declared sterile, 120 implantable.
Devices declared under this manufacturer
- Alpha Dent Implants
- Cell Implants
- Megatork
Showing 12 of 120 declared devices.
Catalogue references include IAK 3.3x6, IAK 4.2x13, IIS 3.8x10, IIS 4.2x11.5, IIS 5x6, IM 3.8x11.5.
European nomenclature codes declared: P01020101.
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 |
Device-level evidence
| Devices with a numeric GTIN | 120 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Alpha Dent Implants GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
26 0085 QR/NB | issued | 2031-03-15 |
25 0445 QR/NB | issued | 2030-11-20 |