# K202046: LOTA SLA Dental Implant System and LOTA HA Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Mar 1, 2022 after 586 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: 11 generations back to K894595 (1990). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103810: KJ Submerged System, Kj Meditech Co., Ltd. (2011) Summary page 4.
- K161923: J2A SLA Dental Implant System, Kj Meditech Co., Ltd. (2017) Summary page 5.

## Indications for use
The LOTA SLA Dental Implant System and LOTA HA 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 LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Source page: https://510kreport.com/device/K202046
Methodology: https://510kreport.com/methodology