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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 K123627
Device Name ET SMARTFIT ABUTMENT
Applicant
HIOSSEN INC.
85 BEN FAIRLESS DRIVE
FAIRLESS HILLS,  PA  19030
Applicant Contact PATRICK LIM
Correspondent
HIOSSEN INC.
85 BEN FAIRLESS DRIVE
FAIRLESS HILLS,  PA  19030
Correspondent Contact PATRICK LIM
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/23/2012
Decision Date 06/28/2013
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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