Identity
- Trade Name
- EzDent-i FDA UDI
- Generic Name
- General-purpose dental x-ray system application software FDA UDI
- Device Name
- EzDent-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. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. FDA UDI
- Model / Reference
- v2.2 FDA UDI
- Description
- EzDent-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. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019700050 FDA UDI
- 510(k) Number
- K163533 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-i by Ewoosoft Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose dental x-ray system application software.
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- 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 8dbc3f44-7fff-4b95-adc7-16c21536b3cf 34 fields · synced May 30, 2026