# K070905: Endosseous Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants, Inc.
- Decided: May 24, 2007 after 52 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894595 (1990). 65 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 83 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.
- K061169: Endosseous Dental Implant, Northern Implants, LLC (2006) Summary page 1.
- K964220: Replace Titanium Implant System, Steri-Oss, Inc. (1997) Summary page 1.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 1.

## Most influential descendants
- K163634: External Hex Implants (2017), 13 descendants of its own
- K163060: Deep Conical (DC) Implants and Accessories (2017), 7 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

## Recalls of this device
- Sep 13, 2013 · Class II · Z-0382-2014: Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package con

## Indications for use
The NSI Implant System 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 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/K070905
Methodology: https://510kreport.com/methodology