# K983742: Iti Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Mar 15, 1999 after 143 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: 1 generation back to K894593 (1990). 7 ancestors in all.
510 later devices descend from it; 7 cite it directly.
0 of 518 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894593: Bonefit Hollow Cylinder Implants, Institut Straumann AG (1990) Summary page 1.
- K894595: Bonefit R Screw Implants, Institut Straumann AG (1990) Summary page 1.
- K971578: Endosseous Dental Implant, Straumann USA (1997) Summary page 1.
- K954512: Restore Self Tapping Dental Implant System, Lifecore Biomedical, Inc. (1996) Summary page 1.
- K960288: HA & TPS Restore Self Tapping Dental Implant System, Lifecore Biomedical, Inc. (1996) Summary page 1.
- K954347: 3I Standard Threaded Implant, Implant Innovations, Inc. (1996) Summary page 1.
- K960417: 3I STND Threaded/Self Tapping Threaded/3I Miniplant Implants/3 I Emergence Prof. Temp. Healing Abutments, Implant Innovations, Inc. (1996) Summary page 1.
- (no number) Nobel Biocare Branemark implants: named in the summary without a submission number

## 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
ITI dental implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K983742
Methodology: https://510kreport.com/methodology