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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K151626
Device Name ET III Bio-SA Fixture System
Applicant
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Applicant Contact David Kim
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact David Kim
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/17/2015
Decision Date 07/21/2016
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
Recalls CDRH Recalls
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