# K251084: zirkon; structure; LFU shades, stains and glazes

- Pathway: 510(k) (Abbreviated)
- Applicant: Estetic Ceram AG
- Decided: Jun 5, 2025 after 57 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: 6 generations back to K024250 (2003). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192251: Livento Press, Soprano 10, Soprano, Cendres+Metaux SA (2020). Our reading of the summary gave K192551, FDA’s number for 1ml Luer Slip or Luer Lock Syringe, Syringe with… (Jiangsu Caina Medical Co.,Ltd). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Soprano 10, Soprano surface and Soprano”.

## Indications for use
Types of restorations: 1. Anterior and posterior crowns 2. Veneers, inlays, onlays.

Source page: https://510kreport.com/device/K251084
Methodology: https://510kreport.com/methodology