# K241391: Straumann® PURE Ceramic Implants

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Dec 10, 2024 after 209 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: 6 generations back to K022562 (2002). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171769: Straumann PURE Ceramic Implants, Straumann USA, LLC (On Behalf of Institut Straumann Ag) (2017) Summary page 6.

## Indications for use
The Straumann® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components. The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

Source page: https://510kreport.com/device/K241391
Methodology: https://510kreport.com/methodology