Medical Device Manufacturer · ZA , Irene

Southern Implants (Pty), Ltd. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2016

Recent clearances: External Hex Implant System, Single Platform SP1 Implant System, Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Southern Implants (Pty), Ltd. Dental ✕

17 devices

1-12 of 17

Cleared Apr 01, 2024

External Hex Implant System

Cleared Dec 01, 2023

Single Platform SP1 Implant System

Cleared Aug 01, 2023

Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments

Cleared Apr 17, 2023

Cleared Mar 06, 2023

Provata Implant System

Cleared Nov 09, 2022

Zaga Zygomatic System

Cleared Oct 27, 2020

TIB Abutment System

Cleared May 07, 2020

ZAGA Zygomatic System

Cleared Dec 09, 2019

Southern Implants MAX Implant System

Cleared Dec 05, 2019

Southern Implants PEEK Abutments

Cleared Nov 14, 2018

Inversa Implants

Cleared Sep 06, 2018

Provata Implant System