FDA 510(k)

高速空氣涡轮手柄

K 號：K202371 · 2021-11-08

申請人Beijing Dongbo Dental Handpiece Co., Ltd.

決定日期2021-11-08

產品代碼EFB

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Beijing Dongbo Dental Handpiece Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：EFB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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