Southern Implants (Pty), Ltd. is one of 8 FDA 510(k) medical device manufacturers from South Africa in the dataset, ranked by real submission volume.
Southern Implants (Pty), Ltd. - FDA 510(k) Cleared Devices
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
Southern Implants (Pty), Ltd. has 19 FDA 510(k) cleared dental devices. Based in Irene, ZA.
Latest FDA clearance: Apr 2024. Active since 2016.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by PaxMed International, LLC and Regulatory Insight, Inc..
FDA 510(k) Regulatory Record - Southern Implants (Pty), Ltd.
19 devices
Cleared
Apr 01, 2024
External Hex Implant System
Dental
208d
Cleared
Dec 01, 2023
Single Platform SP1 Implant System
Dental
112d
Cleared
Aug 01, 2023
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
Dental
124d
Cleared
Apr 17, 2023
TIB Abutments
Dental
244d
Cleared
Mar 06, 2023
Provata Implant System
Dental
203d
Cleared
Nov 09, 2022
Zaga Zygomatic System
Dental
83d
Cleared
Mar 02, 2022
Southern Implants Instrument Trays
General Hospital
338d
Cleared
Oct 27, 2020
TIB Abutment System
Dental
357d
Cleared
May 07, 2020
ZAGA Zygomatic System
Dental
226d
Cleared
Dec 09, 2019
Southern Implants MAX Implant System
Dental
234d
Cleared
Dec 05, 2019
Southern Implants PEEK Abutments
Dental
210d
Cleared
Nov 14, 2018
Inversa Implants
Dental
126d