Identity
- Trade Name
- EzDent Web FDA UDI
- Generic Name
- General-purpose dental x-ray system application software FDA UDI
- Device Name
- EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equipped with management and processing system for various 2D and 3D images. In addition, EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software. EzDent Web provides you with the following functions using patient images in 2D and 3D. - Manage patient information - View patient images in 2D/3D using tools for image processing and view function. - Use high resolution 3D VR to view 3D images in the optimized view for user intent. - Consult patients using media contents provided for patient consultation. FDA UDI
- Model / Reference
- v1.2 FDA UDI
- Description
- EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equipped with management and processing system for various 2D and 3D images. In addition, EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software. EzDent Web provides you with the following functions using patient images in 2D and 3D. - Manage patient information - View patient images in 2D/3D using tools for image processing and view function. - Use high resolution 3D VR to view 3D images in the optimized view for user intent. - Consult patients using media contents provided for patient consultation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019700395 FDA UDI
- 510(k) Number
- K230468 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
EzDent Web 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 |
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Manufacturer
- Manufacturer
- Ewoosoft Co., Ltd.
Sources (1)
- FDA UDI af2cc73c-c4b3-4c64-955e-b3694c43d852 34 fields · synced May 29, 2026