# K071148: Atlas Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Feb 6, 2008 after 288 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: 7 generations back to K944964 (1995). 53 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050635: Allfim Implant Systems, Cowellmedi Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K120043: CSM Internal-R Implant System (2012), 1 descendant of its own
- K090054: Atlas Implant System - Wide Plus (2009), 1 descendant of its own
- K173141: CSM Submerged3-L Implant System (2018), 0 descendants of its own
- K090377: Sinus Quick EB System (2009), 0 descendants of its own

## Indications for use
Atlas Implant Systems are designed for use in dental implant surgery. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. They are not intended for use of immediate loading.

Source page: https://510kreport.com/device/K071148
Methodology: https://510kreport.com/methodology