# K003620: Nsi Hexed and Non-Hexed Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Nsi
- Decided: Sep 19, 2001 after 301 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
No predicates in its family tree.
37 later devices descend from it; 10 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020617: Nsi Hexed and Non-Hexed Implant System (2002), 36 descendants of its own
- K033171: Nsi Hexed and Non-Hexed Implant System and Immediate Loading (2004), 32 descendants of its own
- K052490: Endosseous Dental Implant System (2005), 31 descendants of its own
- K053478: Endosseous Dental Implant System (2006), 30 descendants of its own
- K061169: Endosseous Dental Implant (2006), 24 descendants of its own

Source page: https://510kreport.com/device/K003620
Methodology: https://510kreport.com/methodology