# K090825: SQ IS System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Jul 16, 2009 after 112 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: 8 generations back to K894595 (1990). 24 ancestors in all.
55 later devices descend from it; 5 cite it directly.
0 of 80 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 2.
- K073465: US/GS Ultra Wide System, Osstem Implant Co., Ltd. (2008) Summary page 2.
- K073058: Rescue Internal Implant System, Megagen Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K113554: Cmi Implant IS System (2012), 34 descendants of its own
- K181138: IS-III active System (2018), 23 descendants of its own
- K120951: Smartbuilder System (2012), 14 descendants of its own
- K120503: Cmi Implant IS II Active (2012), 9 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own

## Indications for use
The SQ IS 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. IS System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

Source page: https://510kreport.com/device/K090825
Methodology: https://510kreport.com/methodology