# K150060: J2A Dental Implant System, J2C Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Apr 2, 2015 after 79 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: 9 generations back to K894595 (1990). 19 ancestors in all.
2 later devices descend 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)
- K121047: Hero II Dental Implant System, IS Dental Implant System, Kj Meditech Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K161923: J2A SLA Dental Implant System (2017), 1 descendant of its own
- K202046: LOTA SLA Dental Implant System and LOTA HA Dental Implant System (2022), 0 descendants of its own

## Indications for use
The J2A Dental Implant System and J2C Dental Implant System are 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 Dental Implant System and J2C Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Source page: https://510kreport.com/device/K150060
Methodology: https://510kreport.com/methodology