FDA 510(k)

HF-Etchant 氢氟酸蚀刻凝胶

K号: K242530 · 2024-12-20

申请人Rizhao Huge Biomaterials Company, Ltd.

决定日期2024-12-20

产品代码KLE

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决定实质等同

器械摘要

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.

常见问题

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.

列明Rizhao Huge Biomaterials Company, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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