Alphadent NV
Active in EUDAMEDBelgiumfrom SRN EUDAMED FDA SRN BE-MF-000000923
Alphadent NV is a medical device manufacturer based in Belgium, with 356 devices listed in FDA GUDID and EUDAMED (FDA Class I and II; EU Class I) as of 14 Nov 2026.
- Devices
- 356
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 353
- EUDAMED 12
- Device classes
- FDA Class I 337
- EU Class I 12
- FDA Class II 7
- Top EMDN categories
- Identifiers
- EUDAMED SRN BE-MF-000000923
- DUNS 283174985
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Alphadent NV makes
Alphadent NV produces dental impression tools and space maintainers for pediatric patients, including analogues for M3-sized teeth and activating tools. Their portfolio also includes reamers, post systems for dental restorations (e.g., PRECI-POST sets and individual components), and specialized space maintainers like the CEKA M3 and REVAX M2. These products are designed for use in pediatric dentistry and endodontic procedures.
All listed devices fall under EU Medical Device Regulation (MDR) Class I, ensuring compliance with basic safety and performance requirements. The products are registered in the EU’s eudamed database, a mandatory digital registry for medical devices marketed within the European Economic Area. The manufacturer is based in Belgium.
Catalogue
Search and filter all 356 devicesShowing 1-50 of 356
Company details
- EUDAMED SRN
- BE-MF-000000923
- DUNS number
- 283174985
- EU VAT number
- BE 0414.789.321
- EUDAMED status
- Active
- EUDAMED registered name
- Alphadent NV
- Registered address
- 33, Mannebeekstraat, 8790, Waregem, Belgium
- Website
- www.ceka-preciline.com/
- Phone
- +32 56 62 91 05
- PRRC contact
- Mark Zielke
FDA establishments
- Alpha-Dent US
Frequently asked questions
How many devices does Alphadent NV have in the registry?
The registry currently lists 356 devices for Alphadent NV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alphadent NV's devices?
Among its 50 most recently registered devices, Alphadent NV has devices listed in FDA GUDID (50 devices).
What risk classes do Alphadent NV's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Alphadent NV's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Alphadent NV in the registry?
The most recently registered devices listed for Alphadent NV include CEKA & PRECI-LINE ATTACHMENTS 1804, CEKA & PRECI-LINE ATTACHMENTS 694 AR, CEKA & PRECI-LINE ATTACHMENTS 2954D and CEKA & PRECI-LINE ATTACHMENTS 1102 P.
Which FDA establishments are linked to Alphadent NV?
1 FDA establishment is linked to Alphadent NV in the registry; they are listed on the company page.