# K130604: Universal Paste Stains and Glaze

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Sep 12, 2013 after 189 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 K812116 (1981). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090718: Bellus Shading Kit, 3M Espe AG Dental Products (2009) Summary page 1.

## Indications for use
Prismatik's Universal Paste Stains and Glaze are intended to be used in dental applications for coloration and finishing of glass ceramic and zirconia-based restorations.

Source page: https://510kreport.com/device/K130604
Methodology: https://510kreport.com/methodology