# K050903: Xawex G 100

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Jun 23, 2005 after 73 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: 1 generation back to K013230 (2001). 1 ancestor in all.
251 later devices descend from it; 5 cite it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013230: Cercon Base, Degussa - Ney Dental, Inc. (2001) Summary page 1.

## Most influential descendants
- K072569: Metoxit Cam-Blanks (2007), 186 descendants of its own
- K061804: Zerion Alpha, ; Zerion Beta (2006), 171 descendants of its own
- 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

## Indications for use
Xavex G100 is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations. It is a partially sintered yttria stabilized zirconium oxide powder that has to be machined with the CAD/CAM technique to its required shape and then sintered to full density. Xavex G100 is recommended for manufacturing substructures of single tooth and bridgework with up to two pontics, which can be used in the anterior as well as in the posterior tooth region.

Source page: https://510kreport.com/device/K050903
Methodology: https://510kreport.com/methodology