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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 K241063
Device Name s-Clean ScanHealing Abutment
Applicant
Dentis Co., Ltd.
99, Seongseoseo-Ro
Dalseo-Gu,  KR 42718
Applicant Contact Gyu Ri Kim
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/18/2024
Decision Date 07/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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