Identity
- Trade Name
- Ez3D-i FDA UDI
- Generic Name
- General-purpose dental x-ray system application software FDA UDI
- Device Name
- Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. FDA UDI
- Model / Reference
- 5.4 FDA UDI
- Description
- Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019700340 FDA UDI
- 510(k) Number
- K222069 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- General-purpose dental x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose dental x-ray system application software
Ez3D-i by Ewoosoft Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose dental x-ray system application software.
- Midmark Progeny Imaging Software — Midmark Corporation · Class II
- Visix — Televere Systems · Class II
- EVA SELECT — ImageWorks · Class II
- TigerView — Televere Systems · Class II
- VisionX — DÜRR DENTAL SE · Class II
- Visix — Televere Systems · Class II
- ImageXL — PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC · Class II
- VisionX — DÜRR DENTAL SE · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ewoosoft Co., Ltd.
Sources (1)
- FDA UDI 154c08b4-1b09-46af-9750-3f2ffe17599d 34 fields · synced Jun 8, 2026