# K081579: Inventus Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Inventus Co., Ltd.
- Decided: Sep 17, 2008 after 104 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: 6 generations back to K894595 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010458: The Maestro System, BioHorizons Implant Systems, Inc. (2001) Summary page 1.
- K062030: US System, Osstem Implant Co., Ltd. (2006) Summary page 1.

## Indications for use
The Inventus Implant System is a series of titanium endosseous dental implants and accessories for surgical implantation in the upper and/or lower jaw. It is intended to artificially provide a root structure to support prosthetic devices, such as artificial teeth, in order to restore the chewing function of the patient.

Source page: https://510kreport.com/device/K081579
Methodology: https://510kreport.com/methodology
