# K231557: ZENEX FreeMilling & CCM Cast Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Izenimplant Co., Ltd.
- Decided: Aug 24, 2023 after 86 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K894595 (1990). 74 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 4.
- K192263: UCLA CCM Abutment, Dio Corporation (2020) Summary page 4.

## Most influential descendants
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own
- K253334: ZENEX Implant System_Short (R-System) (2026), 0 descendants of its own

## Indications for use
The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Source page: https://510kreport.com/device/K231557
Methodology: https://510kreport.com/methodology