# K250063: ARENA Star, Galaxy Star

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Jul 10, 2025 after 181 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: 13 generations back to K830955 (1983). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223253: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc), Arum Dentistry Co., Ltd. (2023) Summary page 5.

## Indications for use
Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. All zirconia block are processed through dental laboratories or by dental professionals.

Source page: https://510kreport.com/device/K250063
Methodology: https://510kreport.com/methodology