EzOrtho

GUDID 08800019700258

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.

EWOO SOFT Co., Ltd

General-purpose dental x-ray system application software
Primary Device ID08800019700258
NIH Device Record Key9f097654-644c-4b19-9203-98f1904c83f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEzOrtho
Version Model Number1.2
Company DUNS688379797
Company NameEWOO SOFT Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800019700258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-16
Device Publish Date2021-11-08

On-Brand Devices [EzOrtho]

08800019700203EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image
08800019700159EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image
08800019700258EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image
08800019700319EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image

Trademark Results [EzOrtho]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EZORTHO
EZORTHO
79261429 not registered Live/Pending
EWOO SOFT Co., Ltd.
2019-04-25

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