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

Duns Number:688379797

Device Description: EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxil

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More Product Details

Catalog Number

-

Brand Name

EzDent-i

Version/Model Number

v3.2

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

K211795

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

645202cd-4eeb-463e-b59c-27ad83a87139

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