# K033171: Nsi Hexed and Non-Hexed Implant System and Immediate Loading

- Pathway: 510(k) (Traditional)
- Applicant: Northern Implants, LLC
- Decided: Apr 27, 2004 after 210 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: 5 generations back to K894595 (1990). 45 ancestors in all.
32 later devices descend from it; 6 cite it directly.
0 of 78 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.
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 1.
- K970499: Branemark System Zygomaticus Fixture System, Nobel Biocare Uas, Inc. (1997) Summary page 1.
- K894593: Bonefit Hollow Cylinder Implants, Institut Straumann AG (1990) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.
- K024111: Astra Tech Implants-Dental System Fixture Osseospeed, Astra Tech, Inc. (2003) Summary page 1.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 1.
- K024004: Xive Transgingival Dental Implant System, Friadent GmbH (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K012965: Astra Dental Implants. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K052490: Endosseous Dental Implant System (2005), 31 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
- K070905: Endosseous Dental Implant System (2007), 17 descendants of its own
- K082651: Endosseous Dental Implant System (2008), 14 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 placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Source page: https://510kreport.com/device/K033171
Methodology: https://510kreport.com/methodology