FDA 510(k)

TopCEM-Try in Veneer Try-in Gel

Número K: K242572 · 2024-12-20

RequerenteRizhao Huge Biomaterials Company, Ltd.

Data da decisão2024-12-20

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TopCEM-Try in Veneer Try-in Gel is the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242572. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TopCEM-Try in Veneer Try-in Gel?

TopCEM-Try in Veneer Try-in Gel is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K242572.

When did TopCEM-Try in Veneer Try-in Gel receive FDA 510(k) clearance?

TopCEM-Try in Veneer Try-in Gel received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242572.

Who is the listed applicant for TopCEM-Try in Veneer Try-in Gel?

The FDA 510(k) record lists Rizhao Huge Biomaterials Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TopCEM-Try in Veneer Try-in Gel?

The FDA product code for TopCEM-Try in Veneer Try-in Gel is EBF.

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Fonte oficial

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