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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 K192688
Device Name s-Clean SQ-SL Implant System Regular
Applicant
Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu
Daegu,  KR 42718
Applicant Contact Gyu Ri Kim
Correspondent
Withus Group Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/26/2019
Decision Date 02/04/2020
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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