FDA 510(k)

Bright MTA Sealer Plus

K号: K231480 · 2023-07-28

决定日期2023-07-28

产品代码KIF

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决定实质等同

器械摘要

Bright MTA Sealer Plus is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K231480. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bright MTA Sealer Plus?

Bright MTA Sealer Plus is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K231480.

When did Bright MTA Sealer Plus receive FDA 510(k) clearance?

Bright MTA Sealer Plus received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231480.

Who is the listed applicant for Bright MTA Sealer Plus?

The FDA 510(k) record lists Genoss Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bright MTA Sealer Plus?

The FDA product code for Bright MTA Sealer Plus is KIF.

列明Genoss Co., 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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