# K103810: KJ Submerged System

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Sep 14, 2011 after 259 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: 1 generation back to K972417 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101849: Bicon Dental Implant System 3.0MM Bicon Dental Implant, Bicon, LLC (2010) Summary page 2.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 1.
- K073368: 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant, Bicon, LLC (2008) Summary page 1.
- K062044: The 5.0 X 6.0MM Dental Implant, Bicon, Inc. (2006) Summary page 1.
- K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant, Bicon, Inc. (2005) Summary page 1.
- K042637: The 5.0 X 6.0MM Dental Implant, Bicon, Inc. (2004) Summary page 1.
- K010185: 6.0 X 5.7MM Dental Implant, Bicon, Inc. (2002) Summary page 2.
- K994037: The 4.5MM Diameter Bicon Dental Implant, Bicon, Inc. (2000) Summary page 1.
- K972417: The 6.0 X 8.0MM Dental Implant System, Bicon, Inc. (1997) Summary page 1.

## Most influential descendants
- K202046: LOTA SLA Dental Implant System and LOTA HA Dental Implant System (2022), 0 descendants of its own

## Indications for use
The KJ Submerged 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. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading.

Source page: https://510kreport.com/device/K103810
Methodology: https://510kreport.com/methodology