# K171769: Straumann PURE Ceramic Implants

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC (On Behalf of Institut Straumann Ag)
- Decided: Nov 14, 2017 after 153 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: 5 generations back to K022562 (2002). 9 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151328: PURE Ceramic Implants, Straumann USA (2016) Summary page 4.

## Most influential descendants
- K180477: Straumann PURE Ceramic Implant System (2019), 6 descendants of its own
- K190654: Straumann CI RD Ceramic Healing Caps (2019), 2 descendants of its own
- K231803: Neodent Implant System - Zirconia Implant System (2023), 1 descendant of its own
- K192893: Straumann Ceramic Healing Abutments (2020), 1 descendant of its own
- K192053: W Zirconia Implants (2019), 1 descendant of its own

## Indications for use
The Straumann® PURE Ceramic Implant (Monotype) 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/K171769
Methodology: https://510kreport.com/methodology