EzDent-i / E2 / Prora View

System, Image Processing, Radiological

EWOO SOFT Co., Ltd.

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

Pre-market Notification Details

Device IDK190087
510k NumberK190087
Device Name:EzDent-i / E2 / Prora View
ClassificationSystem, Image Processing, Radiological
Applicant EWOO SOFT 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. 1150 Roosevelt, STE 200 Irvine,  CA  92620
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-17
Decision Date2019-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800019700111 K190087 000
08800019700180 K190087 000

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