# K190112: Non-Sterile Zirconia Block

- Pathway: 510(k) (Traditional)
- Applicant: Fine Advanced Compound Co., Ltd.
- Decided: Dec 20, 2019 after 331 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: 11 generations back to K830955 (1983). 20 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180252: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank, Crown Porcelain Dental Technology Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K223253: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) (2023), 1 descendant of its own
- K250063: ARENA Star, Galaxy Star (2025), 0 descendants of its own
- K201492: Non-Sterile Zirconia Block (2021), 0 descendants of its own

## Indications for use
Non-Sterile Zirconia Block (Model: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Source page: https://510kreport.com/device/K190112
Methodology: https://510kreport.com/methodology