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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K160106
Device Name LUNA DENTAL IMPLANT SYSTEM
Applicant
Shinhung Mst Co., Ltd.
110-2, Donghwagongdan-Ro, Munmak-Eup
Wonju-Si,  KR 220-801
Applicant Contact Sunbyung Lee
Correspondent
Shinhung Mst Co., Ltd.
110-2, Donghwagongdan-Ro, Munmak-Eup
Wonju-Si,  KR 220-801
Correspondent Contact Sunbyung Lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/19/2016
Decision Date 08/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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