FDA 510(k)

DENU 复合树脂, DENU 流动树脂

K号: K213339 · 2022-09-23

决定日期2022-09-23

产品代码EBF

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决定实质等同

器械摘要

DENU Composite Resin, DENU Flow Resin is the device name listed in this FDA 510(k) record. The listed applicant is Hdi, Inc.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K213339. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DENU Composite Resin, DENU Flow Resin?

DENU Composite Resin, DENU Flow Resin is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Hdi, Inc.. The 510(k) number is K213339.

When did DENU Composite Resin, DENU Flow Resin receive FDA 510(k) clearance?

DENU Composite Resin, DENU Flow Resin received FDA 510(k) clearance on 2022-09-23, under 510(k) number K213339.

Who is the listed applicant for DENU Composite Resin, DENU Flow Resin?

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

What is the FDA product code for DENU Composite Resin, DENU Flow Resin?

The FDA product code for DENU Composite Resin, DENU Flow Resin is EBF.

列明Hdi, Inc.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。

K222741DENU 轻体(常规, 快速), DENU 重体(常规, 快速), DENU 油泥套装(常规, 快速)

官方来源

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