ARENA Star, Galaxy Star
K-Number: K250063 · 2025-07-10
ApplicantArum Dentistry Co., Ltd.
Decision Date2025-07-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ARENA Star, Galaxy Star is a medical device manufactured by Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2025-07-10 under approval number K250063. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARENA Star, Galaxy Star?
ARENA Star, Galaxy Star is a medical device that received FDA 510(k) clearance on 2025-07-10. It is manufactured by Arum Dentistry Co., Ltd.. The 510(k) number is K250063.
When was ARENA Star, Galaxy Star approved by the FDA?
ARENA Star, Galaxy Star received FDA 510(k) clearance on 2025-07-10, under approval number K250063.
What company makes ARENA Star, Galaxy Star?
ARENA Star, Galaxy Star is manufactured by Arum Dentistry Co., Ltd..
What is the FDA product code for ARENA Star, Galaxy Star?
The FDA product code for ARENA Star, Galaxy Star is EIH.
Other Devices by Arum Dentistry Co., Ltd.
Related Devices (Code: EIH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.