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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 K191250
Device Name Southern Implants PEEK Abutments
Southern Implants (Pty) Ltd
1 Albert Road
irene,  ZA 0062
Applicant Contact lauranda breytenbach
Southern Implants (Pty) Ltd
1 Albert Road
irene,  ZA 0062
Correspondent Contact lauranda breytenbach
Regulation Number872.3630
Classification Product Code
Date Received05/09/2019
Decision Date 12/05/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No