# K071161: Endosseous Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants, Inc.
- Decided: Nov 16, 2007 after 204 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894595 (1990). 51 ancestors in all.
6 later devices descend from it; 6 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)
- K003620: Nsi Hexed and Non-Hexed Implant System, Nsi (2001) Summary page 1.
- K020617: Nsi Hexed and Non-Hexed Implant System, Nsi (2002) Summary page 1.
- 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.
- K053478: Endosseous Dental Implant System, Northern Implants, LLC (2006) Summary page 1.
- K053353: Rescue Implant System, Megagen Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K191054: Southern Implants MAX Implant System (2019), 1 descendant of its own
- K122664: Zuga Dental Implant System (2013), 1 descendant of its own
- K110337: Universal Maxillary Molar (2012), 1 descendant of its own
- K201334: Keystone Dental XL Dental Implant System (2020), 0 descendants of its own
- K171197: Zuga Dental Implant System (2018), 0 descendants of its own

## Recalls of this device
- Jun 16, 2017 · Class II · Z-0718-2018: An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
- Jan 23, 2015 · Class II · Z-1265-2015: Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.

## Indications for use
The NSI MAX Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to morbidity. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Source page: https://510kreport.com/device/K071161
Methodology: https://510kreport.com/methodology