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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 K181850
Device Name Inversa Implants
Applicant
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Applicant Contact Lauranda 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  
Date Received07/11/2018
Decision Date 11/14/2018
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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