# K223253: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Feb 27, 2023 after 129 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: 12 generations back to K830955 (1983). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190112: Non-Sterile Zirconia Block, Fine Advanced Compound Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K250063: ARENA Star, Galaxy Star (2025), 0 descendants of its own

## Indications for use
Non-Sterile Zirconia Block (Model name: ARENA Star, Mont Blanc) 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/K223253
Methodology: https://510kreport.com/methodology