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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 K222636
Device Name ET Abutment System
Applicant
Hiossen Inc.
85 Ben Fairless Drive
Fairless Hills,  PA  19030
Applicant Contact Peter Lee
Correspondent
Hiossen Inc.
85 Ben Fairless Drive
Fairless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/31/2022
Decision Date 04/28/2023
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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