# K171784: Straumann Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Jan 19, 2018 after 218 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: 12 generations back to K894595 (1990). 71 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130222: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 4.

## Most influential descendants
- K212538: DESS Dental Implants (2021), 1 descendant of its own
- K251280: DESS® Dental Implants (2025), 0 descendants of its own
- K223083: Straumann SLActive labeling changes (2023), 0 descendants of its own
- K202095: CreoDent Solidex Customized Abutment and Screw (2020), 0 descendants of its own

## Indications for use
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

Source page: https://510kreport.com/device/K171784
Methodology: https://510kreport.com/methodology