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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 K171027
Device Name Dentis Dental Implant System
Applicant
Dentis Co., Ltd.
99, Seongseoseo-Ro
Dalseo-Gu
Daegu,  KR 42718
Applicant Contact Sun Chul Shin
Correspondent
Withus Group, Inc.
2531 Pepperdale Dr.
Rowland Heights,  CA  91748
Correspondent Contact April Lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/05/2017
Decision Date 09/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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