# K081419: Straumann Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Feb 20, 2009 after 276 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: 8 generations back to K894595 (1990). 36 ancestors in all.
142 later devices descend from it; 5 cite it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053088: Slactive Implants, Institut Straumann AG (2006) Summary page 1.

## Most influential descendants
- K122855: TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants (2012), 123 descendants of its own
- 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

## 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. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

Source page: https://510kreport.com/device/K081419
Methodology: https://510kreport.com/methodology