FDA 510(k)

HF-Etchant Hydrofluoric Acid Etching Gel

Número K: K242530 · 2024-12-20

RequerenteRizhao Huge Biomaterials Company, Ltd.

Data da decisão2024-12-20

Código do produtoKLE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

HF-Etchant Hydrofluoric Acid Etching 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 K242530. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HF-Etchant Hydrofluoric Acid Etching Gel?

HF-Etchant Hydrofluoric Acid Etching 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 K242530.

When did HF-Etchant Hydrofluoric Acid Etching Gel receive FDA 510(k) clearance?

HF-Etchant Hydrofluoric Acid Etching Gel received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242530.

Who is the listed applicant for HF-Etchant Hydrofluoric Acid Etching 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 HF-Etchant Hydrofluoric Acid Etching Gel?

The FDA product code for HF-Etchant Hydrofluoric Acid Etching Gel is KLE.

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Fonte oficial

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