# K211978: Jplant

- Pathway: 510(k) (Traditional)
- Applicant: Jj Medical Co., Ltd.
- Decided: Jan 5, 2022 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: 11 generations back to K894595 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160536: Chaorum Implant System, Medimecca Co., Ltd. (2017) Summary page 5.

## Indications for use
Jplant is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Jplant is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K211978
Methodology: https://510kreport.com/methodology