# K173116: KJ ZIRCONIA Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Jun 28, 2018 after 272 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 K022562 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061971: Zirconia Implant, Nobel Biocare AB (2007) Summary page 4.

## Indications for use
The KJ ZIRCONIA Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. It is for delayed loading.

Source page: https://510kreport.com/device/K173116
Methodology: https://510kreport.com/methodology