# K232726: External Hex Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Apr 1, 2024 after 208 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K925765 (1993). 221 ancestors in all.
No later device cites it as a predicate yet.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163634: External Hex Implants, Southern Implants (Pty), Ltd. (2017) Summary page 6.
- K160119: NobelSpeedy Groovy, Nobel Biocare AB (2016) Summary page 6.
- K212785: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments, Blue Sky Bio, LLC (2022) Summary page 6.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 6.

## Indications for use
For Standard Length IBR36d Implant Range: 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. When using Southern Implants' Standard Length IBR36D Implants with angulation of 36° a minimum of 4 implants must be used and splinted The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration. For Extra Length IBR36d Implant Range: 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. Extra Length IBR36d Implants can be placed bicortically in cases of reduced bone density. Extra Length IBR36d Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Extra Length IBR36d Implants are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration. For Extra Length IBR24d Implant Range: Southern Implants’ External Hex Implants are intended for surgical placement in the upper 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. Southern Implants’ Extra Length IBR24d Implant Range when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

Source page: https://510kreport.com/device/K232726
Methodology: https://510kreport.com/methodology