# K231264: Easy On Universal Glaze & Stain

- Pathway: 510(k) (Traditional)
- Applicant: Doctus Global
- Decided: Jun 30, 2023 after 59 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: 5 generations back to K024250 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193588: DD Contrast, Dental Direkt GmbH (2020) Summary page 5.

## Indications for use
Easy On Universal Glaze & Stain is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.

Source page: https://510kreport.com/device/K231264
Methodology: https://510kreport.com/methodology