EzDent-i/ E2/ Prora View/ Smart M Viewer

System, Image Processing, Radiological

Ewoosoft Co., Ltd.

The following data is part of a premarket notification filed by Ewoosoft Co., Ltd. with the FDA for Ezdent-i/ E2/ Prora View/ Smart M Viewer.

Pre-market Notification Details

Device IDK211795
510k NumberK211795
Device Name:EzDent-i/ E2/ Prora View/ Smart M Viewer
ClassificationSystem, Image Processing, Radiological
Applicant Ewoosoft Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil Hwaseong-si,  KR 18449
ContactYoung Seok Kim
CorrespondentPriscilla Chung
Lk Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine,  CA  92612
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-10
Decision Date2021-10-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800019700227 K211795 000

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