# K061176: Straumann Dental Implants

- Pathway: 510(k) (Special)
- Applicant: Institut Straumann AG
- Decided: Aug 11, 2006 after 106 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: 4 generations back to K894595 (1990). 18 ancestors in all.
148 later devices descend from it; 5 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033922: Modification to Iti Dental Implant System, Institut Straumann AG (2004) Summary page 1.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 1.
- K010291: Iti Dental Implant System, Straumann USA (2001) Summary page 1.

## Most influential descendants
- K101096: HT Iii SA Fixture System (2010), 104 descendants of its own
- K120847: ET/SS Implant System (2012), 75 descendants of its own
- K121585: TS Implant System (2013), 64 descendants of its own
- K140507: Hiossen Prosthetic System (2014), 44 descendants of its own
- K130662: ET Prosthetic System (2014), 42 descendants of its own

## Indications for use
Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients for single-stage or two-stage surgery. The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant.

Source page: https://510kreport.com/device/K061176
Methodology: https://510kreport.com/methodology