EzDent Web - EzDent Web is a dental imaging software that - EWOO SOFT Co., Ltd

Duns Number:688379797

Device Description: EzDent Web is a dental imaging software that enables you to save, manage, view and process 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.

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More Product Details

Catalog Number

-

Brand Name

EzDent Web

Version/Model Number

v1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K211700

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

2ad8cf18-51a6-4cde-a05a-11bf04698fc4

Public Version Date

November 16, 2021

Public Version Number

1

DI Record Publish Date

November 08, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EWOO SOFT CO., LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24