# K072425: Jne Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: GC America, Inc.
- Decided: Mar 10, 2008 after 194 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: 7 generations back to K894595 (1990). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971196: Endopore Endosseous Dental Implant System, Innova Corp. (1997) Summary page 1.
- K002513: Astra Tech Implants - Dental System, Astra Tech, Inc. (2001) Summary page 1.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 1.

## Most influential descendants
- K093749: GC Aadva Implant System (2010), 0 descendants of its own

## Indications for use
The INE Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.

Source page: https://510kreport.com/device/K072425
Methodology: https://510kreport.com/methodology