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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2025-07-10 under 510(k) 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. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K250063.

When did ARENA Star, Galaxy Star receive FDA 510(k) clearance?

ARENA Star, Galaxy Star received FDA 510(k) clearance on 2025-07-10, under 510(k) number K250063.

Who is the listed applicant for ARENA Star, Galaxy Star?

The FDA 510(k) record lists Arum Dentistry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARENA Star, Galaxy Star?

The FDA product code for ARENA Star, Galaxy Star is EIH.

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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.

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