# K031055: Iti Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Jul 7, 2003 after 95 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: 2 generations back to K935544 (1995). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013570: Osseotite Dental Implants, Implant Innovations, Inc. (2001) Summary page 1.
- (no number) ITI Dental Implant System: named in the summary without a submission number

## Most influential descendants
- K050586: Leone Implant System (2006), 2 descendants of its own
- K092674: Simpler Toadstool Mini Implant (2009), 0 descendants of its own
- K073622: Easy Grip Dental Implant System (2008), 0 descendants of its own
- K070483: Leone Monoimplant for O-Ring Overdenture (2007), 0 descendants of its own

## Indications for use
ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures.

Source page: https://510kreport.com/device/K031055
Methodology: https://510kreport.com/methodology