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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 K170421
Device Name ET Hybrid Abutment
Applicant
Hiossen Inc.
85 Ben Fairless Dr.
Fairless Hills,  PA  19030
Applicant Contact David Kim
Correspondent
Hiossen Inc.
85 Ben Fairless Dr.
Fairless Hills,  PA  19030
Correspondent Contact David Kim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/13/2017
Decision Date 01/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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