# K161923: J2A SLA Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Nov 9, 2017 after 484 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: 10 generations back to K894595 (1990). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150060: J2A Dental Implant System, J2C Dental Implant System, Kj Meditech Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K202046: LOTA SLA Dental Implant System and LOTA HA Dental Implant System (2022), 0 descendants of its own

## Indications for use
The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. These systems are intended for delayed loading.

Source page: https://510kreport.com/device/K161923
Methodology: https://510kreport.com/methodology