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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K171694
Device Name s-Clean TiN Coating Abutments
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 Number872.3630
Classification Product Code
NHA  
Date Received06/07/2017
Decision Date 11/29/2017
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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