# K121098: Hero I Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Jan 17, 2013 after 281 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032774: Renova Internal Hex Implant System, Lifecore Biomedical, Inc. (2003) Summary page 1.
- K121047: Hero II Dental Implant System, IS Dental Implant System, Kj Meditech Co., Ltd. (2012). Cleared while this submission was under review Summary page 1.

## Cited in the summary but kept off the family tree
- K110577: Osseofuse Dental Implant System, Dynamic Innovations, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Hero I 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 Hero I Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.

Source page: https://510kreport.com/device/K121098
Methodology: https://510kreport.com/methodology