# K033922: Modification to Iti Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Institut Straumann AG
- Decided: Jan 7, 2004 after 20 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894595 (1990). 16 ancestors in all.
346 later devices descend from it; 10 cite it directly.
0 of 363 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983742: Iti Dental Implant System, Institut Straumann AG (1999) Summary page 1.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 1.

## Most influential descendants
- K101207: Neodent Implant System (2010), 181 descendants of its own
- K101945: Neodent Implant System (2011), 180 descendants of its own
- K061176: Straumann Dental Implants (2006), 148 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own

## Recalls of this device
- Mar 12, 2012 · Not classified · Z-1351-2012: Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN

## 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. ITI Dental Implants are for single-stage or two-stage surgery. ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

Source page: https://510kreport.com/device/K033922
Methodology: https://510kreport.com/methodology