# K033430: 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615

- Pathway: 510(k) (Special)
- Applicant: Implant Innovations, Inc.
- Decided: Nov 7, 2003 after 10 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). 12 ancestors in all.
213 later devices descend from it; 2 cite it directly.
0 of 226 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972444: 3I Innovative Implants and Cover Screws, Implant Innovations, Inc. (1997) Summary page 1.
- K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants, Implant Innovations, Inc. (2003)

## Most influential descendants
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite (2007), 211 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K150295: LOCATOR RTx (2015), 42 descendants of its own

## Indications for use
3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.

Source page: https://510kreport.com/device/K033430
Methodology: https://510kreport.com/methodology