# K181850: Inversa Implants

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Nov 14, 2018 after 126 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). 217 ancestors in all.
No later device cites it as a predicate yet.
0 of 218 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 4.

## Indications for use
Inversa 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. Inversa Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Source page: https://510kreport.com/device/K181850
Methodology: https://510kreport.com/methodology