Identity
- Trade Name
- EzOrtho FDA UDI
- Generic Name
- General-purpose dental x-ray system application software FDA UDI
- Device Name
- EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019700159 FDA UDI
- 510(k) Number
- K192888 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
EzOrtho 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.
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- 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 51794ec8-da09-435e-890e-717d64c75e47 34 fields · synced Jun 6, 2026