Luna Dental Implant System- Healing Abutment

Abutment, Implant, Dental, Endosseous

Shinhung MST Co., Ltd.

The following data is part of a premarket notification filed by Shinhung Mst Co., Ltd. with the FDA for Luna Dental Implant System- Healing Abutment.

Pre-market Notification Details

Device IDK200189
510k NumberK200189
Device Name:Luna Dental Implant System- Healing Abutment
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Shinhung MST Co., Ltd. 110-2, Donghwagong-Ro Munmak-Eup Wonju Si,  KR 220-801
ContactJae Soo Song
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine,  CA  92620
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-27
Decision Date2020-02-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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