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

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/ Smart M Viewer.

Pre-market Notification Details

Device IDK202116
510k NumberK202116
Device Name:EzDent-i/ E2/ Prora View/ Smart M Viewer
ClassificationSystem, Image Processing, Radiological
Applicant Ewoo Soft Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil Hwaseong-si,  KP 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-30
Decision Date2020-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000
08800019700197 K202116 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.