FDA 510(k)

空壓手持式工具及手持式附件

K 號：K162926 · 2017-02-23

決定日期2017-02-23

產品代碼EFB

諮詢委員會DE

決定相當於

器材摘要

Air-Powered Handpieces and Handpiece Attachments is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Burmoos GmbH. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K162926. 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 Air-Powered Handpieces and Handpiece Attachments?

Air-Powered Handpieces and Handpiece Attachments is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is W&H Dentalwerk Burmoos GmbH. The 510(k) number is K162926.

When did Air-Powered Handpieces and Handpiece Attachments receive FDA 510(k) clearance?

Air-Powered Handpieces and Handpiece Attachments received FDA 510(k) clearance on 2017-02-23, under 510(k) number K162926.

Who is the listed applicant for Air-Powered Handpieces and Handpiece Attachments?

The FDA 510(k) record lists W&H Dentalwerk Burmoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air-Powered Handpieces and Handpiece Attachments?

The FDA product code for Air-Powered Handpieces and Handpiece Attachments is EFB.

其他以 W&H Dentalwerk Burmoos GmbH 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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