FDA 510(k)

X-Smart Pro; X-Smart Pro+

K 號：K233865 · 2024-07-24

決定日期2024-07-24

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

X-Smart Pro; X-Smart Pro+ is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K233865. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X-Smart Pro; X-Smart Pro+?

X-Smart Pro; X-Smart Pro+ is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K233865.

When did X-Smart Pro; X-Smart Pro+ receive FDA 510(k) clearance?

X-Smart Pro; X-Smart Pro+ received FDA 510(k) clearance on 2024-07-24, under 510(k) number K233865.

Who is the listed applicant for X-Smart Pro; X-Smart Pro+?

FDA 510(k) 記錄將 Dentsply Sirona, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for X-Smart Pro; X-Smart Pro+?

The FDA product code for X-Smart Pro; X-Smart Pro+ is EKX.

其他以 Dentsply Sirona, Inc. 為申請人之記錄

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相關器械（代碼：EKX）

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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