# K082651: Endosseous Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants, Inc.
- Decided: Dec 22, 2008 after 101 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 K894595 (1990). 47 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033171: Nsi Hexed and Non-Hexed Implant System and Immediate Loading, Northern Implants, LLC (2004) Summary page 1.
- K052490: Endosseous Dental Implant System, Northern Implants, LLC (2005) Summary page 1.
- K970499: Branemark System Zygomaticus Fixture System, Nobel Biocare Uas, Inc. (1997) Summary page 1.

## Most influential descendants
- K163634: External Hex Implants (2017), 13 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K180465: Provata Implant System (2018), 2 descendants of its own
- K231967: ARi ExCon Implant System (2023), 1 descendant of its own

## Indications for use
The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment.

Source page: https://510kreport.com/device/K082651
Methodology: https://510kreport.com/methodology