# K152023: Luminesse Shaded Zirconia SZ

- Pathway: 510(k) (Traditional)
- Applicant: Talladium, Inc.
- Decided: Sep 15, 2016 after 422 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 K060104 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130924: Bruxzir Shaded, Prismatik Dentalcraft, Inc. (2013) Summary page 5.

## Indications for use
Luminesse Shaded Zirconia SZ blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic patient specific dental restorations - full contour crowns and bridges for anterior and posterior location - as prescribed by a dentist.

Source page: https://510kreport.com/device/K152023
Methodology: https://510kreport.com/methodology