# Southern Implants (Pty), Ltd.

- Location (FDA's records): Guateng, ZA
- FDA decisions: 24 (2007–2024): 24 510(k) clearances
- Names in FDA's records: Southern Implants (Pty), Ltd. (19); Southern Implants, Inc. (5)
- Product codes: DZE (17), NHA (5), FZE (1), KCT (1)
- 510(k) review time since 2016: median 207 days, against 200 for FDA's reviews in the same codes and years (10 of 18 faster)
- Predicates its devices cite: 84 (24 its own); citations of its devices by later devices: 43 (24 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Northern Implants, LLC: 18 (https://510kreport.com/company/northern-implants)
- Nsi: 10 (https://510kreport.com/company/nsi)
- Nobel Biocare AB: 6 (https://510kreport.com/company/nobel-biocare)
- Nobel Biocare Uas, Inc.: 3 (https://510kreport.com/company/nobel-biocare-uas)
- Implant Direct Sybron Manufacturing, LLC: 2 (https://510kreport.com/company/implant-direct-sybron-manufacturing)
- Astra Tech, Inc.: 2 (https://510kreport.com/company/astra-tech)
- Biomet 3i, Inc.: 2 (https://510kreport.com/company/biomet-3i)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)

## Firms that cite its devices most
- Zuga Medical, Inc.: 4 (https://510kreport.com/company/zuga-medical)
- Oco Biomedical: 2 (https://510kreport.com/company/oco-biomedical)
- Implacil DE Bortoli Material Odontologico Ltda: 2 (https://510kreport.com/company/implacil-de-bortoli-material-odontologico)
- Keystone Dental, Inc.: 2 (https://510kreport.com/company/keystone-dental)
- Smart Denture Conversions, LLC: 2 (https://510kreport.com/company/smart-denture-conversions)
- D.S.P Industrial Eireli: 1 (https://510kreport.com/company/dsp-industrial-eireli)
- Odontit S.A.: 1 (https://510kreport.com/company/odontit)
- Megagen Implant Co., Ltd.: 1 (https://510kreport.com/company/megagen-implant)

## Its most-cited devices
- K163634: External Hex Implants (2017), cited by 8
- K071161: Endosseous Dental Implant System (2007), cited by 6
- K070841: Endosseous Dental Implant System (2007), cited by 5
- K070905: Endosseous Dental Implant System (2007), cited by 4
- K193084: TIB Abutment System (2020), cited by 3
- K163060: Deep Conical (DC) Implants and Accessories (2017), cited by 3

## Recent decisions
- K232726: External Hex Implant System (Apr 1, 2024)
- K232418: Single Platform SP1 Implant System (Dec 1, 2023)
- K230873: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (Aug 1, 2023)
- K222469: TIB Abutments (Apr 17, 2023)
- K222457: Provata Implant System (Mar 6, 2023)
- K222497: Zaga Zygomatic System (Nov 9, 2022)
- K210923: Southern Implants Instrument Trays (Mar 2, 2022)
- K193084: TIB Abutment System (Oct 27, 2020)

Source page: https://510kreport.com/company/southern-implants