# K080195: Nacera Z and Nacera Z Medium

- Pathway: 510(k) (Traditional)
- Applicant: Doceram Medical Ceramics GmbH
- Decided: Apr 28, 2008 after 94 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K013230 (2001). 3 ancestors in all.
167 later devices descend from it; 2 cite it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061804: Zerion Alpha, ; Zerion Beta, Etkon International GmbH (2006) Summary page 1.

## Most influential descendants
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own

## Indications for use
Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state. Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations. It is prepared for machining by use of CAM-techniques. The machined frameworks like dental crown and bridge works are sintered to full density.

Source page: https://510kreport.com/device/K080195
Methodology: https://510kreport.com/methodology