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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 K233389
Device Name EK Digital Abutments
Applicant
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Applicant Contact Peter Lee
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/02/2023
Decision Date 05/29/2024
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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