# K180477: Straumann PURE Ceramic Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jan 4, 2019 after 316 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.
6 later devices descend from it; 3 cite it directly.
0 of 17 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 4.

## Most influential descendants
- 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
- K232383: iPhysio® System (2025), 0 descendants of its own

## Indications for use
Straumann PURE Ceramic Implant: The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components. Closure and healing caps: Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months. Temporary Abutments: The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days. CI RD Straumann PUREbase Abutments: CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

Source page: https://510kreport.com/device/K180477
Methodology: https://510kreport.com/methodology