# K161593: GMI Frontier Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ilerimplant S.L
- Decided: Jan 19, 2017 after 224 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: 5 generations back to K925765 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 5.

## Indications for use
GMI Frontier Dental Implant System model is intended to be used for surgical placement in upper or lower jaw to provide a support for prosthetic devices such as artificial teeth, in order to restore the patient's chewing function. The GMI Frontier Dental Implants System is intended for delayed loading.

Source page: https://510kreport.com/device/K161593
Methodology: https://510kreport.com/methodology