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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 K153268
Device Name NR Line Implant System
Applicant
Dentium Co., Ltd.
29 Teheran-Ro, 87-Gzl
Gangnam-Gu
Seoul,  KR 06167
Applicant Contact YOUNJUNG YUK
Correspondent
Denterprise International, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact CLAUDE BERTHOIN
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/12/2015
Decision Date 07/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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