# K190569: Shaders ZR

- Pathway: 510(k) (Traditional)
- Applicant: Digital Age Dental Lab
- Decided: Jul 29, 2019 after 145 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 K062509 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062509: Incoris ZI, Sirona Dental Systems GmbH (2006) Summary page 6.

## Indications for use
Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns, and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a dental professional or dental laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions.

Source page: https://510kreport.com/device/K190569
Methodology: https://510kreport.com/methodology