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FDA 510(k)

Enamel Coating Resin

K-Number: K230455 · 2023-07-25

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2023-07-25
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Enamel Coating Resin is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2023-07-25 under approval number K230455. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enamel Coating Resin?

Enamel Coating Resin is a medical device that received FDA 510(k) clearance on 2023-07-25. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K230455.

When was Enamel Coating Resin approved by the FDA?

Enamel Coating Resin received FDA 510(k) clearance on 2023-07-25, under approval number K230455.

What company makes Enamel Coating Resin?

Enamel Coating Resin is manufactured by Rizhao Huge Biomaterials Company, Ltd..

What is the FDA product code for Enamel Coating Resin?

The FDA product code for Enamel Coating Resin is EBC.

Related Clinical Trials

NCT07544849 A Randomized Split-Mouth Clinical Trial Comparing Resin Infiltration and Microabrasion for Early Caries Lesions COMPLETED

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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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