# K003271: Modification to Iti Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Mar 20, 2001 after 153 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
No predicates in its family tree.
612 later devices descend from it; 6 cite it directly.
0 of 613 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013798: Prosthetic Accessories to the Iti Dental Implant System (2001), 575 descendants of its own
- K012757: Iti Dental Implant System (2001), 535 descendants of its own
- K020096: Esthetic Ease Abutments for the Iti Dental Implant System (2002), 516 descendants of its own
- K033243: Iti Synocta Meso Abutments (2003), 514 descendants of its own
- K062129: P.0004 Implants (2006), 434 descendants of its own

Source page: https://510kreport.com/device/K003271
Methodology: https://510kreport.com/methodology