# K191895: Straumann Mini Implants

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Dec 9, 2019 after 147 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: 1 generation back to K031106 (2003). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 4.

## Most influential descendants
- K211052: Straumann RidgeFit Implants (2021), 1 descendant of its own
- K250294: Straumann® RidgeFit Implants (2025), 0 descendants of its own
- K200906: MINICONE Implant (2020), 0 descendants of its own

## Indications for use
Straumann® Mini Implants ∅2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Straumann® Mini Implants are intended for the stabilization of removable dentures.

Source page: https://510kreport.com/device/K191895
Methodology: https://510kreport.com/methodology