# K090377: Sinus Quick EB System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Aug 28, 2009 after 192 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: 9 generations back to K944964 (1995). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062030: US System, Osstem Implant Co., Ltd. (2006) Summary page 2.
- K070570: Dio Implant System, Dio Department Dsi, Inc. (2008) Summary page 2.
- K090054: Atlas Implant System - Wide Plus, Cowellmedi Co., Ltd. (2009). Cleared while this submission was under review Summary page 2.

## Indications for use
The SQ EB 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. Smaller (e 3.5, e 4.0, o 5.0) implants are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger (e 6.0, e 7.0, e 8.0) implants are dedicated for the molar region and not indicated for immediate loading.

Source page: https://510kreport.com/device/K090377
Methodology: https://510kreport.com/methodology