# K030007: Iti Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Mar 31, 2003 after 89 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 K894595 (1990). 11 ancestors in all.
570 later devices descend from it; 12 cite it directly.
0 of 582 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984104: Iti Dental Implant System, Straumann USA (1999) Summary page 1.
- K003552: Iti Dental Implant System, Institut Straumann SA (2001) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.

## Most influential descendants
- K033984: Straumann Dental Implant System (2004), 376 descendants of its own
- K033922: Modification to Iti Dental Implant System (2004), 346 descendants of its own
- K053088: Slactive Implants (2006), 295 descendants of its own
- K083550: Straumann Dental Implant System (2009), 228 descendants of its own
- K060958: Straumann Narrow Neck Implants (2006), 228 descendants of its own

## Indications for use
The IT1 dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

Source page: https://510kreport.com/device/K030007
Methodology: https://510kreport.com/methodology