# K100850: Cowell Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Dec 20, 2010 after 269 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). 25 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 30 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.
- K053353: Rescue Implant System, Megagen Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K132242: Inno Sla Submerged Implant System (2013), 3 descendants of its own
- K201323: INNO SLA Submerged Implant System (2022), 2 descendants of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K251605: DIMPLO Implant System (2025), 0 descendants of its own

## Indications for use
The Cowell 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. The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

Source page: https://510kreport.com/device/K100850
Methodology: https://510kreport.com/methodology