Alpha Dent Implants GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000007046 FEI 3015383403
- Devices
- 366
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
What Alpha Dent Implants GmbH makes
Alpha Dent Implants GmbH manufactures dental implant systems designed for osseointegrated tooth replacement, including abutments and implant fixtures for single-tooth and multi-tooth restorations.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance in the United States. The dental implants are listed in the FDA’s 510(k) premarket notification database.
Catalogue
Search and filter all 366 devicesShowing 1-50 of 366
Company details
- EUDAMED SRN
- DE-MF-000007046
- FDA FEI number
- 3015383403
- DUNS number
- 314932959
- EU VAT number
- DE 316968685
- EUDAMED status
- Active
- EUDAMED registered name
- Alpha Dent Implants GmbH
- EUDAMED abbreviated name
- Alpha Dent Implants GmbH
- Registered address
- 1-5, Hanauer Straße, 75181, Pforzheim, Germany
- Website
- alpha-dent.net
- [email protected]
- Phone
- +49 17678531156
- PRRC contact
- Alla Prokosheva
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 20 Nov 2030
Notified body 1023 2 certificates
- 26 0085 QR/NB Issued
Quality management system EU MDR
- Issued
- 16 Mar 2026
- Expires
- 15 Mar 2031
- 25 0445 QR/NB Issued
Quality management system EU MDR
- Issued
- 21 Nov 2025
- Expires
- 20 Nov 2030
Frequently asked questions
How many devices does Alpha Dent Implants GmbH have in the registry?
The registry currently lists 366 devices for Alpha Dent Implants GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alpha Dent Implants GmbH's devices?
Among its 50 most recently registered devices, Alpha Dent Implants GmbH has devices listed in EUDAMED (4 devices) and FDA GUDID (46 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Alpha Dent Implants GmbH's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Alpha Dent Implants GmbH's devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Alpha Dent Implants GmbH?
EUDAMED lists 2 certificates for Alpha Dent Implants GmbH (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 2026-03-16.
What are the newest devices from Alpha Dent Implants GmbH in the registry?
The most recently registered devices listed for Alpha Dent Implants GmbH include Alpha Dent Implants, Megatork, Alpha Dent Implants Close Tray Transfer 9mm and Alpha Dent Implants Analog For Aesthetic Abutment.