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FDA 510(k)

Light-curing Coloring Materials (ALCM)

K-Number: K253036 · 2026-04-06

Decision Date2026-04-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Light-curing Coloring Materials (ALCM) is a medical device manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under approval number K253036. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Light-curing Coloring Materials (ALCM)?

Light-curing Coloring Materials (ALCM) is a medical device that received FDA 510(k) clearance on 2026-04-06. It is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K253036.

When was Light-curing Coloring Materials (ALCM) approved by the FDA?

Light-curing Coloring Materials (ALCM) received FDA 510(k) clearance on 2026-04-06, under approval number K253036.

What company makes Light-curing Coloring Materials (ALCM)?

Light-curing Coloring Materials (ALCM) is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd..

What is the FDA product code for Light-curing Coloring Materials (ALCM)?

The FDA product code for Light-curing Coloring Materials (ALCM) is EBF.

Related Clinical Trials

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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.