ARENA Star, Galaxy Star— 510(k) K250063

Name: FDA 510(k) clearance K250063
Creator: U.S. Food and Drug Administration
Published: 2025-07-10

Substantially Equivalent

Arum Dentistry Co., Ltd.

FDA 510(k) clearance K250063 for ARENA Star, Galaxy Star, Substantially Equivalent on 2025-07-10. Applicant: Arum Dentistry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Arum Dentistry Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2025-01-10
Decision date: 2025-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.