FDA 510(k)

VarseoSmile 頸冠加

K 號：K201668 · 2020-06-23

申請人Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG

決定日期2020-06-23

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

VarseoSmile Crown plus is the device name listed in this FDA 510(k) record. The listed applicant is Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. It received FDA 510(k) clearance on 2020-06-23 under 510(k) number K201668. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VarseoSmile Crown plus?

VarseoSmile Crown plus is a medical device that received FDA 510(k) clearance on 2020-06-23. The listed applicant is Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. The 510(k) number is K201668.

When did VarseoSmile Crown plus receive FDA 510(k) clearance?

VarseoSmile Crown plus received FDA 510(k) clearance on 2020-06-23, under 510(k) number K201668.

Who is the listed applicant for VarseoSmile Crown plus?

The FDA 510(k) record lists Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VarseoSmile Crown plus?

The FDA product code for VarseoSmile Crown plus is EBF.

其他以 Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG 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。

K233596VarseoSmile TriniQ

相關器械（代碼：EBF）

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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