Internal Hex Implant System

Implant, Endosseous, Root-form

EBI Inc.

The following data is part of a premarket notification filed by Ebi Inc. with the FDA for Internal Hex Implant System.

Pre-market Notification Details

Device IDK190837
510k NumberK190837
Device Name:Internal Hex Implant System
ClassificationImplant, Endosseous, Root-form
Applicant EBI Inc. 124, Uisong-gil, Amnyang-myeon Gyeongsan-si,  KR 38493
ContactDongjun Yang
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-01
Decision Date2020-01-22

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