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FDA 510(k)

Light Cure Composite

K-Number: K240112 · 2024-03-15

ApplicantSincera Technology (Changchun) Co., Ltd.
Decision Date2024-03-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Light Cure Composite is a medical device manufactured by Sincera Technology (Changchun) Co., Ltd.. It received FDA 510(k) clearance on 2024-03-15 under approval number K240112. 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 Cure Composite?

Light Cure Composite is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Sincera Technology (Changchun) Co., Ltd.. The 510(k) number is K240112.

When was Light Cure Composite approved by the FDA?

Light Cure Composite received FDA 510(k) clearance on 2024-03-15, under approval number K240112.

What company makes Light Cure Composite?

Light Cure Composite is manufactured by Sincera Technology (Changchun) Co., Ltd..

What is the FDA product code for Light Cure Composite?

The FDA product code for Light Cure Composite is EBF.

Related Clinical Trials

NCT07598305 PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers COMPLETED NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Other Devices by Sincera Technology (Changchun) Co., Ltd.

K241056Light Cure Adhesive

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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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