# K163634: External Hex Implants

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Nov 6, 2017 after 319 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K925765 (1993). 216 ancestors in all.
13 later devices descend from it; 8 cite it directly.
0 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133049: 3I T3(R) External Hex Dental Implants, Biomet 3i (2014) Summary page 5.
- K003620: Nsi Hexed and Non-Hexed Implant System, Nsi (2001) Summary page 5.
- K020617: Nsi Hexed and Non-Hexed Implant System, Nsi (2002) Summary page 5.
- K082651: Endosseous Dental Implant System, Southern Implants, Inc. (2008) Summary page 5.
- K053478: Endosseous Dental Implant System, Northern Implants, LLC (2006) Summary page 5.
- K070841: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 5.
- K070905: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 5.
- K092341: Low Profile Abutments - Internal and External Connection, Biomet 3i, Inc. (2009) Summary page 5.
- K160244: VARIOunite, Thommen Medical AG (2016) Summary page 5.
- K150669: Neoss TiBase, Neoss CoCr Abutments (Mono and Multi), Neoss, Ltd. (2015) Summary page 5.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 5.

## Most influential descendants
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K180465: Provata Implant System (2018), 2 descendants of its own
- K231967: ARi ExCon Implant System (2023), 1 descendant of its own
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own

## Recalls of this device
- Mar 8, 2018 · Class II · Z-1386-2018: The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.

## Indications for use
Southern Implants’ External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants’ External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Source page: https://510kreport.com/device/K163634
Methodology: https://510kreport.com/methodology