# K012757: Iti Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Straumann USA
- Decided: Aug 22, 2001 after 5 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 K894844 (1990). 4 ancestors in all.
535 later devices descend from it; 11 cite it directly.
0 of 540 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003271: Modification to Iti Dental Implant System, Institut Straumann AG (2001) Summary page 1.
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.

## Most influential descendants
- K062129: P.0004 Implants (2006), 434 descendants of its own
- K033984: Straumann Dental Implant System (2004), 376 descendants of its own
- K053088: Slactive Implants (2006), 295 descendants of its own
- K070478: P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) (2007), 283 descendants of its own
- K072679: P.004 Abutments (2007), 279 descendants of its own

## Indications for use
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K012757
Methodology: https://510kreport.com/methodology