# K130184: Zenolux

- Pathway: 510(k) (Abbreviated)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: May 24, 2013 after 119 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: 4 generations back to K910611 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082257: Zeno AI Eco Disc, Wieland Dental + Technik GmbH & Co. KG (2008) Summary page 1.
- K062506: Incoris AL, Sirona Dental Systems GmbH (2006) Summary page 1.
- K053050: Procera Bridge Alumina, Nobel Biocare AB (2006) Summary page 1.
- K112152: Cercon HT, Dentsply International, Inc. (2011) Summary page 1.
- K112710: Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR, Wieland Dental + Technik GmbH & Co. KG (2011) Summary page 1.

## Indications for use
Zenolux ame milling blanks, which ame intended to be used by professional dental technicians for the CAD/ CAM -fabrication of all-ceramic crowns and 3-unit bridges, in the anterior as well as posterior tooth region. These parts can be used as framework for veneering with suitable dental porcelain and/ or as full-contour monolithic restorations.

Source page: https://510kreport.com/device/K130184
Methodology: https://510kreport.com/methodology