# K130221: Hero II Dental Implant System, UI Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Medimecca Co., Ltd.
- Decided: Mar 21, 2013 after 51 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). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 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 1.
- K110577: Osseofuse Dental Implant System, Dynamic Innovations, Inc. (2011)

## Indications for use
The Hero 11 Dental Implant System and the UI Dental Implant System are indicated for use in partially or fully edlentulous 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 11 Denial Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Source page: https://510kreport.com/device/K130221
Methodology: https://510kreport.com/methodology