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Will3D
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref CNW312Model Will3D510(k) K170180
Identity
- Trade Name
- Will3D EUDAMEDFDA UDI
- Generic Name
- General-purpose dental x-ray system application software FDA UDI
- Device Name
- Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting. FDA UDI
- Model / Reference
- Will3D EUDAMEDFDA UDICNW312 EUDAMED
- Description
- Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800005200298 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000052004LM EUDAMED
- 510(k) Number
- K211114 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030392 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- General-purpose dental x-ray system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Will3D by Hdx Will Corp. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170180 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K211114 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000052004LM | Class IIa | Active |
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Manufacturer
- Manufacturer
- HDX WILL Corp.
- EUDAMED SRN
- KR-MF-000019877
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 78cf2419-223c-4410-8f4e-9b8a4c077d08 85 fields · synced Jun 18, 2026
- FDA UDI e375998f-110c-49c6-84d8-24fc82074855 35 fields · synced May 30, 2026
- FDA 510(k) K170180 1 fields · synced May 18, 2026