# K053478: Endosseous Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Northern Implants, LLC
- Decided: Apr 5, 2006 after 112 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: 2 generations back to K874590 (1988). 11 ancestors in all.
30 later devices descend from it; 8 cite it directly.
0 of 42 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.
- K954347: 3I Standard Threaded Implant, Implant Innovations, Inc. (1996) Summary page 1.

## Most influential descendants
- K061169: Endosseous Dental Implant (2006), 24 descendants of its own
- K070841: Endosseous Dental Implant System (2007), 21 descendants of its own
- K070905: Endosseous Dental Implant System (2007), 17 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own
- K163060: Deep Conical (DC) Implants and Accessories (2017), 7 descendants of its own

## 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/K053478
Methodology: https://510kreport.com/methodology