FDA 510(k)

NextDent 基礎版

K 號：K231388 · 2023-10-20

決定日期2023-10-20

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

NextDent Base is the device name listed in this FDA 510(k) record. The listed applicant is Vertex-Dental B.V.. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K231388. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NextDent Base?

NextDent Base is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K231388.

When did NextDent Base receive FDA 510(k) clearance?

NextDent Base received FDA 510(k) clearance on 2023-10-20, under 510(k) number K231388.

Who is the listed applicant for NextDent Base?

The FDA 510(k) record lists Vertex-Dental B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextDent Base?

The FDA product code for NextDent Base is EBI.

其他以 Vertex-Dental B.V. 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：EBI）

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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