# K090527: Sinus Quick IT System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Jul 14, 2009 after 138 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: 6 generations back to K894595 (1990). 16 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062051: SS System, Osstem Implant Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K181137: IT-III active System (2018), 3 descendants of its own
- K222792: SNUCONE Tissue Level Implant System (2023), 2 descendants of its own
- K242753: SD TL Implant System (2025), 1 descendant of its own
- K120043: CSM Internal-R Implant System (2012), 1 descendant of its own
- K250280: SD TL Implant System (2025), 0 descendants of its own

## Indications for use
The SQ IT 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 System is dedicated for two stage surgical procedures and for immediate loading.

Source page: https://510kreport.com/device/K090527
Methodology: https://510kreport.com/methodology