# K122804: Royal-Dent Eureka Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Intai Technology Corp.
- Decided: May 20, 2013 after 249 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: 10 generations back to K894595 (1990). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063861: GS System, Osstem Implant Co., Ltd. (2007) Summary page 1.
- K091208: GS Iii System, Osstem Implant Co., Ltd. (2010) Summary page 1.

## Indications for use
Royal-Dent Eureka 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. Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures.- It's not for immediate load.

Source page: https://510kreport.com/device/K122804
Methodology: https://510kreport.com/methodology