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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 K172160
Device Name Southern Implants PEEK Abutments
Applicant
Southern Implants (Pty), Ltd.
1 Albert St.
Irene,  ZA 0062
Applicant Contact Lauranda Breytenbach
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/18/2017
Decision Date 02/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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