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FDA 510(k)

Stratasys 真實牙科

K 號：K220771 · 2022-07-07

申請人Stratasys, Ltd.
決定日期2022-07-07
產品代碼EBI
諮詢委員會DE
決定相當於

器材摘要

Stratasys TrueDent is the device name listed in this FDA 510(k) record. The listed applicant is Stratasys, Ltd.. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K220771. 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 Stratasys TrueDent?

Stratasys TrueDent is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Stratasys, Ltd.. The 510(k) number is K220771.

When did Stratasys TrueDent receive FDA 510(k) clearance?

Stratasys TrueDent received FDA 510(k) clearance on 2022-07-07, under 510(k) number K220771.

Who is the listed applicant for Stratasys TrueDent?

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

What is the FDA product code for Stratasys TrueDent?

The FDA product code for Stratasys TrueDent is EBI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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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