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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 K153639
Device Name OneQ-SL s-Clean Implant System
Applicant
Dentis Co., Ltd.
99, Seongseoseo-Ro, Dalseo-Gu
Daegu,  KR 41718
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  
Date Received12/21/2015
Decision Date 04/08/2016
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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