← Back to catalogue
Dental Computed Tomography X-ray System
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref Dentrix 50510(k) K251842
Identity
- Device Name
- Dental Computed Tomography X-ray System EUDAMED
- Model / Reference
- Dentrix 50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974566271027 EUDAMED
- Basic UDI-DI
- B-06974566271027 EUDAMED
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Computed Tomography X-ray System by Fussen Technology Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251842 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06974566271027 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fussen Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009373
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 809163d9-0bdf-4467-984e-cd0bc091f4e0 85 fields · synced Jun 18, 2026
- FDA 510(k) K251842 1 fields · synced May 18, 2026