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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 K251427
Device Name EK MULTI ANGLED 30 ABUTMENT
Applicant
Hiossen, Inc.
85 Ben Fairless Dirve
Fairless Hills,  PA  19030
Applicant Contact Mateusz Leszczak
Correspondent
Hiossen, Inc.
85 Ben Fairless Dirve
Fairless Hills,  PA  19030
Correspondent Contact Martin Shin
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received05/08/2025
Decision Date 01/29/2026
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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