Cleared Traditional

ARENA Star, Galaxy Star

K250063 · Arum Dentistry Co., Ltd. · Dental
Jul 2025
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K250063 is an FDA 510(k) clearance for the ARENA Star, Galaxy Star, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on July 10, 2025, 181 days after receiving the submission on January 10, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K250063 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2025
Decision Date July 10, 2025
Days to Decision 181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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