# K062432: Nanotite Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Feb 22, 2007 after 185 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: 8 generations back to K925765 (1993). 61 ancestors in all.
59 later devices descend from it; 3 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051461: 3I Osseotite Dental Implants, Implant Innovations, Inc. (2005) Summary page 1.

## Most influential descendants
- K062636: Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental Implants (2007), 28 descendants of its own
- K100724: Osseotite II Model Xifossxxx (2011), 27 descendants of its own
- K122300: T3 Dental Implant (2013), 22 descendants of its own
- K111216: Osseotite 2 Dental Implants (2011), 21 descendants of its own
- K133049: 3I T3(R) External Hex Dental Implants (2014), 19 descendants of its own

## Indications for use
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.

Source page: https://510kreport.com/device/K062432
Methodology: https://510kreport.com/methodology