# K061169: Endosseous Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Northern Implants, LLC
- Decided: Jun 20, 2006 after 54 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). 60 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 85 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.
- K894595: Bonefit R Screw Implants, Institut Straumann AG (1990) Summary page 1.
- K955281: Endosseous Dental Implant & Accessories, The Straumann Co. (1996) Summary page 1.
- K012757: Iti Dental Implant System, Straumann USA (2001) Summary page 1.
- K013798: Prosthetic Accessories to the Iti Dental Implant System, Institut Straumann AG (2001) Summary page 1.
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.
- K962023: Plastic Protection Healing Caps, The Straumann Co. (1996) Summary page 1.

## Most influential descendants
- 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
- K193084: TIB Abutment System (2020), 3 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/K061169
Methodology: https://510kreport.com/methodology