# K181137: IT-III active System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Nov 16, 2018 after 200 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: 7 generations back to K894595 (1990). 17 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090527: Sinus Quick IT System, Neobiotech Co., Ltd. (2009) Summary page 4.

## Most influential descendants
- K222792: SNUCONE Tissue Level Implant System (2023), 2 descendants of its own
- K242753: SD TL Implant System (2025), 1 descendant of its own
- K250280: SD TL Implant System (2025), 0 descendants of its own

## Indications for use
The IT-III active 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. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K181137
Methodology: https://510kreport.com/methodology