# K121131: BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Jun 6, 2012 after 54 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894595 (1990). 41 ancestors in all.
124 later devices descend from it; 4 cite it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083550: Straumann Dental Implant System, Straumann USA (2009) Summary page 1.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 1.

## Most influential descendants
- K123784: Straumann Dental Implant System (2013), 122 descendants of its own
- 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

## Recalls of this device
- Sep 24, 2014 · Class II · Z-0174-2015: Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

## Indications for use
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used 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 by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants.. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Source page: https://510kreport.com/device/K121131
Methodology: https://510kreport.com/methodology