# K262195: Dandy Ceramic Stain and Glaze

- Pathway: 510(k) (Traditional)
- Applicant: Zima International Inc., dba Dandy
- Decided: Jun 30, 2026 after 1 day
- 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 K043462 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250673: CERABIEN MiLai, Kuraray Noritake Dental, Inc. (2025) Summary page 5.

## Indications for use
For use in prosthetic dentistry to create an all-ceramic prosthesis. Ceramic for coverage of a zirconia substructure

Source page: https://510kreport.com/device/K262195
Methodology: https://510kreport.com/methodology