EzDent-i /E2/Prora View

System, Image Processing, Radiological

LK Consulting Group USA, Inc.

The following data is part of a premarket notification filed by Lk Consulting Group Usa, Inc. with the FDA for Ezdent-i /e2/prora View.

Pre-market Notification Details

Device IDK150747
510k NumberK150747
Device Name:EzDent-i /E2/Prora View
ClassificationSystem, Image Processing, Radiological
Applicant LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton,  CA  92831
ContactPriscilla Chung
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton,  CA  92831
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-23
Decision Date2015-04-02
Summary:summary

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