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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K230438
Device Name URIS Smart Path Implant System & Prosthetic
Applicant
TruAbutment Inc.
17666 Fitch
Irvine,  CA  92614
Applicant Contact Ki Yoon Nam
Correspondent
TruAbutment Inc.
17666 Fitch
Irvine,  CA  92614
Correspondent Contact Chris Kim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/21/2023
Decision Date 12/29/2023
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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