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FDA 510(k)

Dental Lithium Disilicate Glass-Ceramic

K-Number: K230487 · 2023-07-03

ApplicantFuzhou Rick Brown Biomaterials Co., Ltd.
Decision Date2023-07-03
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Lithium Disilicate Glass-Ceramic is a medical device manufactured by Fuzhou Rick Brown Biomaterials Co., Ltd.. It received FDA 510(k) clearance on 2023-07-03 under approval number K230487. 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 Dental Lithium Disilicate Glass-Ceramic?

Dental Lithium Disilicate Glass-Ceramic is a medical device that received FDA 510(k) clearance on 2023-07-03. It is manufactured by Fuzhou Rick Brown Biomaterials Co., Ltd.. The 510(k) number is K230487.

When was Dental Lithium Disilicate Glass-Ceramic approved by the FDA?

Dental Lithium Disilicate Glass-Ceramic received FDA 510(k) clearance on 2023-07-03, under approval number K230487.

What company makes Dental Lithium Disilicate Glass-Ceramic?

Dental Lithium Disilicate Glass-Ceramic is manufactured by Fuzhou Rick Brown Biomaterials Co., Ltd..

What is the FDA product code for Dental Lithium Disilicate Glass-Ceramic?

The FDA product code for Dental Lithium Disilicate Glass-Ceramic 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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