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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 K220440
Device Name Dentis s-Clean Abutment Mini
Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu
Daegu,  KR 42718
Applicant Contact Gyu Ri Kim
Withus Group Inc
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
Date Received02/16/2022
Decision Date 06/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No