# K020617: Nsi Hexed and Non-Hexed Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Nsi
- Decided: May 10, 2002 after 74 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: 1 generation back to K874590 (1988). 9 ancestors in all.
36 later devices descend from it; 9 cite it directly.
0 of 46 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.
- K951111: Restore Self Tapping Dental Implant System (3.4MM), Lifecore Biomedical, Inc. (1995) Summary page 1.
- K944068: Restore Self Tapping Dental Implant Syst (5, 5.5,6MM), Lifecore Biomedical, Inc. (1995) Summary page 1.
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 1.
- K894594: Bonefit Hollow Screw Implants, Institut Straumann AG (1990) Summary page 1.
- K925773: Branemark System Gold Cylinders and Screws, Nobelpharma USA, Inc. (1993) Summary page 1.
- K002475: Replace TPS Coated Implants, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K925769: Branemark System Abutments Complete, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925777: Branemark System Estheticone Abutment Complete, Nobelpharma USA, Inc. (1993) Summary page 1.

## Most influential descendants
- 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
- K070841: Endosseous Dental Implant System (2007), 21 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.

Source page: https://510kreport.com/device/K020617
Methodology: https://510kreport.com/methodology