FDA 510(k)

光固化牙科粘合剂

K号: K201787 · 2020-09-25

申请人Rizhao Huge Biomaterials Company, Ltd.

决定日期2020-09-25

产品代码KLE

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决定实质等同

器械摘要

Light Cure Dental Adhesive 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 2020-09-25 under 510(k) number K201787. 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 Light Cure Dental Adhesive?

Light Cure Dental Adhesive is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K201787.

When did Light Cure Dental Adhesive receive FDA 510(k) clearance?

Light Cure Dental Adhesive received FDA 510(k) clearance on 2020-09-25, under 510(k) number K201787.

Who is the listed applicant for Light Cure Dental Adhesive?

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 Light Cure Dental Adhesive?

The FDA product code for Light Cure Dental Adhesive 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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官方来源

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