FDA 510(k)

牙醫高速手持機，牙醫低速手持機

K 號：K181900 · 2019-12-09

申請人Foshan Cicada Dental Instrument Co, Ltd.

決定日期2019-12-09

產品代碼EFB

諮詢委員會DE

決定相當於

器材摘要

Dental high speed handpiece, Dental low speed handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Cicada Dental Instrument Co, Ltd.. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K181900. 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 Dental high speed handpiece, Dental low speed handpiece?

Dental high speed handpiece, Dental low speed handpiece is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Foshan Cicada Dental Instrument Co, Ltd.. The 510(k) number is K181900.

When did Dental high speed handpiece, Dental low speed handpiece receive FDA 510(k) clearance?

Dental high speed handpiece, Dental low speed handpiece received FDA 510(k) clearance on 2019-12-09, under 510(k) number K181900.

Who is the listed applicant for Dental high speed handpiece, Dental low speed handpiece?

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

What is the FDA product code for Dental high speed handpiece, Dental low speed handpiece?

The FDA product code for Dental high speed handpiece, Dental low speed handpiece is EFB.

其他以 Foshan Cicada Dental Instrument Co, Ltd. 為申請人之記錄

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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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