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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 K241003
Device Name HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
Applicant
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Applicant Contact Peter Lee
Correspondent
IZiel Healthcare
Pentagon P1, Office # 601 And 604 Magarpatta City
Hadapsar
Pune,  IN 411028
Correspondent Contact Ankur Naik
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/12/2024
Decision Date 01/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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