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FDA 510(k)

Curing Light, Model: MaxCure 9

K-Number: K223414 · 2023-11-15

ApplicantGuilin Refine Medical Instrument Co., Ltd.
Decision Date2023-11-15
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Curing Light, Model: MaxCure 9 is a medical device manufactured by Guilin Refine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-11-15 under approval number K223414. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curing Light, Model: MaxCure 9?

Curing Light, Model: MaxCure 9 is a medical device that received FDA 510(k) clearance on 2023-11-15. It is manufactured by Guilin Refine Medical Instrument Co., Ltd.. The 510(k) number is K223414.

When was Curing Light, Model: MaxCure 9 approved by the FDA?

Curing Light, Model: MaxCure 9 received FDA 510(k) clearance on 2023-11-15, under approval number K223414.

What company makes Curing Light, Model: MaxCure 9?

Curing Light, Model: MaxCure 9 is manufactured by Guilin Refine Medical Instrument Co., Ltd..

What is the FDA product code for Curing Light, Model: MaxCure 9?

The FDA product code for Curing Light, Model: MaxCure 9 is EBZ.

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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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