# K061804: Zerion Alpha, ; Zerion Beta

- Pathway: 510(k) (Traditional)
- Applicant: Etkon International GmbH
- Decided: Oct 6, 2006 after 101 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: 2 generations back to K013230 (2001). 2 ancestors in all.
171 later devices descend from it; 3 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050903: Xawex G 100, Wieland Dental + Technik GmbH & Co. KG (2005) Summary page 1.

## Most influential descendants
- K080195: Nacera Z and Nacera Z Medium (2008), 167 descendants of its own
- 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

## Indications for use
ZERION is a dental ceramic designed for the labrication of dental restorations by dental technicians. ZERION delivery state is a yttria (yttrium oxide) - stabilized tetragonal zirconia (zirconium oxide) powder, already partially sintered and made for machining by use of CAD/CAM-techniques. The machined frameworks (dental crown and bridge works) are then sintered to full density. ZERION is especially designed for use as framework (substructure) for dental restorations including single tooth or bridge type applications on both anterior and posterior locations.

Source page: https://510kreport.com/device/K061804
Methodology: https://510kreport.com/methodology