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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 K201842
Device Name TruBase S
Applicant
TruAbutment Inc.
17742 Cowan
Irvine,  CA  92614
Applicant Contact HoSu Lee
Correspondent
TruAbutment Inc.
17742 Cowan
Irvine,  CA  92614
Correspondent Contact Chris Choi
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/06/2020
Decision Date 06/04/2021
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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