# K123784: Straumann Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Apr 10, 2013 after 121 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: 10 generations back to K894595 (1990). 69 ancestors in all.
122 later devices descend from it; 4 cite it directly.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983742: Iti Dental Implant System, Institut Straumann AG (1999) Summary page 1.
- K012757: Iti Dental Implant System, Straumann USA (2001) Summary page 1.
- K033922: Modification to Iti Dental Implant System, Institut Straumann AG (2004) Summary page 1.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 1.
- K053088: Slactive Implants, Institut Straumann AG (2006) Summary page 1.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 1.
- K081419: Straumann Dental Implant System, Institut Straumann AG (2009) Summary page 1.
- K083550: Straumann Dental Implant System, Straumann USA (2009) Summary page 1.
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System, Straumann USA (2011) Summary page 1.
- K121131: BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM, Straumann USA (2012) Summary page 1.
- K122855: TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants, Straumann USA (2012). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K130222: Straumann Dental Implant System (2013), 118 descendants of its own
- K140878: Straumann Bone Level Tapered Implant (2014), 105 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own

## Indications for use
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches 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). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Source page: https://510kreport.com/device/K123784
Methodology: https://510kreport.com/methodology