# K151328: PURE Ceramic Implants

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Jan 11, 2016 after 238 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: 4 generations back to K022562 (2002). 8 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120793: Z-LOOK3 Evo SLM, Z-Systems AG (2012) Summary page 5.

## Most influential descendants
- K171769: Straumann PURE Ceramic Implants (2017), 8 descendants of its own
- K180477: Straumann PURE Ceramic Implant System (2019), 6 descendants of its own
- K172668: W Zirconia Implants (2018), 4 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

## 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. The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months. Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.

Source page: https://510kreport.com/device/K151328
Methodology: https://510kreport.com/methodology