# K100511: Cotec Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cotec Implant Co., Ltd.
- Decided: Jul 9, 2010 after 137 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 K894595 (1990). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090825: SQ IS System, Neobiotech Co., Ltd. (2009) Summary page 2.
- K090527: Sinus Quick IT System, Neobiotech Co., Ltd. (2009) Summary page 2.

## Indications for use
The Cotec Dental Implant 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. This system is not intended for immediate loading.

Source page: https://510kreport.com/device/K100511
Methodology: https://510kreport.com/methodology