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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
TruAbutment Inc.
17742 Cowan
Irvine,  CA  92614
Applicant Contact HoSu Lee
TruAbutment Inc.
17742 Cowan
Irvine,  CA  92614
Correspondent Contact Chris Choi
Regulation Number872.3630
Classification Product Code
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