# K140070: Luxer Shaded Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Continental Dental Ceramics, Inc.
- Decided: May 7, 2014 after 114 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 K011394 (2001). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112710: Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR, Wieland Dental + Technik GmbH & Co. KG (2011) Summary page 1.

## Most influential descendants
- K172761: New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) (2017), 2 descendants of its own
- K192535: Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia (2020), 0 descendants of its own
- K181816: Ceramic Denture Zirconia Ceramics Block (2018), 0 descendants of its own
- K161025: priti multidisc ZrO2 High Translucent (2017), 0 descendants of its own

## Indications for use
Luxer Shaded Zirconia blanks are Intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns and bridges) as prescribed by a dentist.

Source page: https://510kreport.com/device/K140070
Methodology: https://510kreport.com/methodology