Implant, Endosseous, Root-form

JJ Medical Co., Ltd.

The following data is part of a premarket notification filed by Jj Medical Co., Ltd. with the FDA for Jplant.

Pre-market Notification Details

Device IDK211978
510k NumberK211978
Device Name:Jplant
ClassificationImplant, Endosseous, Root-form
Applicant JJ Medical Co., Ltd. Daeryung Techno Town 3 409 Gasan-Dong, 115, Gasan Digital 2-Ro, Geumcheon-Gu Seoul,  KR 08505
ContactSun Jae Lee
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine,  CA  92612
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-25
Decision Date2022-01-05

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