# K120792: Tixos Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Leader Italia S.R.L.
- Decided: Sep 5, 2012 after 174 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: 3 generations back to K925765 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062931: Implus Implant System, Leader Italia S.R.L. (2007) Summary page 6.

## Indications for use
TiXos dental implants are permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient in order to restore their original dental function and aesthetic features by providing support for fixed and/or removal prosthesis. TiXos dental implants can support single tooth, multiple tooth, or total prosthesis restorations and are compatible with the following dental abutments manufactured by Leader Italia that were previously cleared under K062931.

Source page: https://510kreport.com/device/K120792
Methodology: https://510kreport.com/methodology