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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 K203649
Device Name TruAbutment DS, TruBase
Applicant
Truabutment, Inc.
17666 Fitch
Irvine,  CA  92614
Applicant Contact Eunjin Jang
Correspondent
Truabutment, Inc.
17666 Fitch
Irvine,  CA  92614
Correspondent Contact Chris Choi
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/14/2020
Decision Date 09/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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