# K062931: Implus Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Leader Italia S.R.L.
- Decided: Nov 28, 2007 after 426 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: 2 generations back to K925765 (1993). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001)
- K021355: Endosseous Implant, Branemark Integration AB (2002) Summary page 1.

## Most influential descendants
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K202832: Implacil Implant System (2021), 0 descendants of its own
- K192839: DSP Implant System (2021), 0 descendants of its own
- K120792: Tixos Implant System (2012), 0 descendants of its own

## Indications for use
IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetics in order to restore original features and masticatory functions. Implus implant fixtures are indicated for permanent use. Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be re-cleaned or re-sterilized.

Source page: https://510kreport.com/device/K062931
Methodology: https://510kreport.com/methodology