ARENA Star, Galaxy Star— 510(k) K250063

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..

Clearance details

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

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