Honorst Implant System

Implant, Endosseous, Root-form

Medimecca Co., Ltd.

The following data is part of a premarket notification filed by Medimecca Co., Ltd. with the FDA for Honorst Implant System.

Pre-market Notification Details

Device IDK202039
510k NumberK202039
Device Name:Honorst Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Medimecca Co., Ltd. Daeryung Techno Town 3-Cha 104,105, 109, 110 Gasan-Dong, 115 Seoul,  KR 08505
ContactSeung Yoon Lee
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine,  CA  92620
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-23
Decision Date2020-09-25

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