Medical Device Manufacturer · ZA , Irene

Southern Implants (Pty), Ltd.

19 submissions · 19 cleared · Since 2016
19
Total
19
Cleared
0
Denied

Southern Implants (Pty), Ltd. — FDA 510(k) Submissions

Southern Implants (Pty), Ltd. has submitted 19 FDA 510(k) premarket notifications since 2016, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Abutment, Implant, Dental, Endosseous, Prosthesis, Nose, Internal, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
External Hex Implant System
K232726 · DZE Implant, Endosseous,... · Dental
Apr 2024 208d
Single Platform SP1 Implant System
K232418 · DZE Implant, Endosseous,... · Dental
Dec 2023 112d
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
K230873 · NHA Abutment, Implant,... · Dental
Aug 2023 124d
TIB Abutments
K222469 · NHA Abutment, Implant,... · Dental
Apr 2023 244d
Provata Implant System
K222457 · DZE Implant, Endosseous,... · Dental
Mar 2023 203d
Zaga Zygomatic System
K222497 · DZE Implant, Endosseous,... · Dental
Nov 2022 83d
Southern Implants Instrument Trays
K210923 · KCT Sterilization Wrap... · General Hospital
Mar 2022 338d
TIB Abutment System
K193084 · NHA Abutment, Implant,... · Dental
Oct 2020 357d
ZAGA Zygomatic System
K192651 · DZE Implant, Endosseous,... · Dental
May 2020 226d
Southern Implants MAX Implant System
K191054 · DZE Implant, Endosseous,... · Dental
Dec 2019 234d
Southern Implants PEEK Abutments
K191250 · NHA Abutment, Implant,... · Dental
Dec 2019 210d
Inversa Implants
K181850 · DZE Implant, Endosseous,... · Dental
Nov 2018 126d
Provata Implant System
K180465 · DZE Implant, Endosseous,... · Dental
Sep 2018 197d
Piccolo Implants and Accessories
K173706 · DZE Implant, Endosseous,... · Dental
Jun 2018 186d
Zygomatic Implant System
K173343 · DZE Implant, Endosseous,... · Dental
Feb 2018 126d
Southern Implants PEEK Abutments
K172160 · NHA Abutment, Implant,... · Dental
Feb 2018 206d
External Hex Implants
K163634 · DZE Implant, Endosseous,... · Dental
Nov 2017 319d
Deep Conical (DC) Implants and Accessories
K163060 · DZE Implant, Endosseous,... · Dental
Jun 2017 224d
Osseointegrated Fixtures
K161548 · FZE Prosthesis, Nose, Internal · General & Plastic Surgery
Dec 2016 181d
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