FDA 510(k)

Highspeed Airturbine Handpiece

K号: K202371 · 2021-11-08

申请人Beijing Dongbo Dental Handpiece Co., Ltd.

决定日期2021-11-08

产品代码EFB

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决定实质等同

器械摘要

Highspeed Airturbine Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K202371. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Highspeed Airturbine Handpiece?

Highspeed Airturbine Handpiece is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. The 510(k) number is K202371.

When did Highspeed Airturbine Handpiece receive FDA 510(k) clearance?

Highspeed Airturbine Handpiece received FDA 510(k) clearance on 2021-11-08, under 510(k) number K202371.

Who is the listed applicant for Highspeed Airturbine Handpiece?

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

What is the FDA product code for Highspeed Airturbine Handpiece?

The FDA product code for Highspeed Airturbine Handpiece is EFB.

列明Beijing Dongbo Dental Handpiece 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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相关器械（代码：EFB）

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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