# K041402: Modification to Osseotite NT Certain Implants

- Pathway: 510(k) (Special)
- Applicant: Implant Innovations, Inc.
- Decided: Jun 16, 2004 after 21 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 K925765 (1993). 57 ancestors in all.
318 later devices descend from it; 5 cite it directly.
0 of 376 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031475: Osseotite NT Certain Implants, Implant Innovations, Inc. (2003) Summary page 1.
- K014235: Osseotite NT Dental Implants & Accessories, Implant Innovations, Inc. (2002) Summary page 1.
- K030614: 3I Dental Implants, Implant Innovations, Inc. (2003) Summary page 1.

## Most influential descendants
- K051189: Prevail Dental Implants (2005), 317 descendants of its own
- K051461: 3I Osseotite Dental Implants (2005), 312 descendants of its own
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite (2007), 211 descendants of its own
- K063341: 3I Osseotite Certain Dental Implants (2007), 209 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own

## Indications for use
Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

Source page: https://510kreport.com/device/K041402
Methodology: https://510kreport.com/methodology
