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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 K161244
Device Name s-Clean OneQ-SL Narrow 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 Drive
Rowland Heights,  CA  91748
Correspondent Contact April Lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/03/2016
Decision Date 12/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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