# K090054: Atlas Implant System - Wide Plus

- Pathway: 510(k) (Traditional)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Jul 29, 2009 after 202 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 K944964 (1995). 69 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071148: Atlas Implant System, Cowellmedi Co., Ltd. (2008) Summary page 2.
- K081302: Rescue External Implant System, Megagen Implant Co., Ltd. (2008) Summary page 2.
- K073465: US/GS Ultra Wide System, Osstem Implant Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K090377: Sinus Quick EB System (2009), 0 descendants of its own

## Indications for use
The Atlas Implant System - Wide Plus 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. Also, there are no angled abutments intended to be used with this system. Smaller (o 4.5, e 5.5) implants are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger (e 6.0 to o 8.0) implants are dedicated for the molar region and not indicated for immediate loading.

Source page: https://510kreport.com/device/K090054
Methodology: https://510kreport.com/methodology