# K211052: Straumann RidgeFit Implants

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jul 8, 2021 after 90 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: 2 generations back to K031106 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191895: Straumann Mini Implants, Institut Straumann AG (2019) Summary page 4.

## Most influential descendants
- K250294: Straumann® RidgeFit Implants (2025), 0 descendants of its own

## Indications for use
Straumann® RidgeFit Implants ∅2.4 mm are for oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved for all implants. Straumann® RidgeFit Implants are intended for the stabilization of removable dentures. • For mandibular restorations, at least 4 Straumann® RidgeFit Implants ∅2.4 mm should be placed. • For maxillary restorations, at least 6 Straumann® RidgeFit Implants ∅2.4 mm should be placed.

Source page: https://510kreport.com/device/K211052
Methodology: https://510kreport.com/methodology