DentiqGuide

System, Image Processing, Radiological

3D Industrial Imaging Co., Ltd

The following data is part of a premarket notification filed by 3d Industrial Imaging Co., Ltd with the FDA for Dentiqguide.

Pre-market Notification Details

Device IDK180629
510k NumberK180629
Device Name:DentiqGuide
ClassificationSystem, Image Processing, Radiological
Applicant 3D Industrial Imaging Co., Ltd 413 Institute Of Computer Technology Seoul National University, Daehak-dong Seoul,  KR 08826
ContactJin Sa Kim
CorrespondentPriscilla Chung
Lk Consulting Group USA, Inc 690 Roosevelt Irvine,  CA  92620
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-09
Decision Date2018-07-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800022900041 K180629 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.