• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name abutment, implant, dental, endosseous
510(k) Number K193084
Device Name TIB Abutment System
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Applicant Contact Lauranda G Breytenbach
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Correspondent Contact Lauranda G Breytenbach
Regulation Number872.3630
Classification Product Code
Subsequent Product Code
Date Received11/05/2019
Decision Date 10/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No