# K121047: Hero II Dental Implant System, IS Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Oct 4, 2012 after 181 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: 8 generations back to K894595 (1990). 18 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072896: GS Fixture System, Osstem Implant Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K131682: UD Implant System (2013), 5 descendants of its own
- K160536: Chaorum Implant System (2017), 3 descendants of its own
- K150060: J2A Dental Implant System, J2C Dental Implant System (2015), 2 descendants of its own
- K161923: J2A SLA Dental Implant System (2017), 1 descendant of its own
- K231932: TDS (Techwin Dental System) (2024), 0 descendants of its own

## Indications for use
The Hero II Dental Implant System and the IS 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 Hero II Dental Implant System and the IS Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Source page: https://510kreport.com/device/K121047
Methodology: https://510kreport.com/methodology