# K033984: Straumann Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jun 30, 2004 after 190 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: 6 generations back to K894595 (1990). 34 ancestors in all.
376 later devices descend from it; 15 cite it directly.
0 of 411 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971578: Endosseous Dental Implant, Straumann USA (1997) Summary page 1.
- K983742: Iti Dental Implant System, Institut Straumann AG (1999) Summary page 1.
- K984104: Iti Dental Implant System, Straumann USA (1999) Summary page 1.
- K003271: Modification to Iti Dental Implant System, Institut Straumann AG (2001) Summary page 1.
- K010291: Iti Dental Implant System, Straumann USA (2001) Summary page 1.
- K012757: Iti Dental Implant System, Straumann USA (2001) Summary page 1.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 1.
- K031674: Modification to Frialit-2 Dental Implant System, Friadent GmbH (2003) Summary page 1.
- K032158: Xive Dental Implant System Multiple, Friadent GmbH (2003) Summary page 1.
- K032284: Xive TG Dental Implant System, Friadent GmbH (2003) Summary page 1.

## Most influential descendants
- 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
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 descendants of its own
- K063364: Alpha Bio Dental Implant System (2007), 187 descendants of its own

## Indications for use
The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System 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 in immediately loaded cases.

Source page: https://510kreport.com/device/K033984
Methodology: https://510kreport.com/methodology