FDA 510(k)

E-Dent 1000

K 號：K210977 · 2021-05-25

決定日期2021-05-25

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

E-Dent 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2021-05-25 under 510(k) number K210977. 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 E-Dent 1000?

E-Dent 1000 is a medical device that received FDA 510(k) clearance on 2021-05-25. The listed applicant is Envisiontec GmbH. The 510(k) number is K210977.

When did E-Dent 1000 receive FDA 510(k) clearance?

E-Dent 1000 received FDA 510(k) clearance on 2021-05-25, under 510(k) number K210977.

Who is the listed applicant for E-Dent 1000?

The FDA 510(k) record lists Envisiontec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Dent 1000?

The FDA product code for E-Dent 1000 is EBF.

其他以 Envisiontec GmbH 為申請人之記錄

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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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