# K250294: Straumann® RidgeFit Implants

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Aug 12, 2025 after 193 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: 3 generations back to K031106 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211052: Straumann RidgeFit Implants, Institut Straumann AG (2021) Summary page 6.

## Indications for use
Straumann® RidgeFit Implants ∅2.4mm are indicated for oral endosteal implantation in the fully edentulous mandible and/or maxilla for the stabilization of removable dentures. 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 on all implants. - Mandibular restorations require at least 4 Straumann® RidgeFit Implants ∅ 2.4 mm. - Maxillary restorations require at least 6 Straumann® RidgeFit Implants ∅ 2.4 mm.

Source page: https://510kreport.com/device/K250294
Methodology: https://510kreport.com/methodology