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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 K191201
Device Name EM SA Implant System
Applicant
Hiossen, Inc.
85 Ben Fairless Drive
Fairless Hills,  PA  19030
Applicant Contact Peter Lee
Correspondent
Hiossen, Inc.
85 Ben Fairless Drive
Fairless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/06/2019
Decision Date 11/15/2019
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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