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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 K202269
Device Name PRE-MILLED Abutment
Applicant
MIT Global Co., Ltd.
474 Dunchon-daero, Jungwon-gu
Seongnam-si,  KR 13229
Applicant Contact Lim Rok Won
Correspondent
MIT Global Co., Ltd.
474 Dunchon-daero, Jungwon-gu
Seongnam-si,  KR 13229
Correspondent Contact Lim Rok Won
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/11/2020
Decision Date 11/25/2020
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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