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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 K173343
Device Name Zygomatic Implant System
Applicant
Southern Implants (Pty) Ltd
1 Albert Road
irene,  ZA 0062
Applicant Contact lauranda g. breytenbach
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
san diego,  CA  92130
Correspondent Contact kevin a. thomas
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/24/2017
Decision Date 02/27/2018
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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