FDA 510(k)

西隆納牙科CAD/CAM系統搭配InLab軟體

K 號：K200191 · 2020-08-19

決定日期2020-08-19

產品代碼PNP

諮詢委員會DE

決定相當於

器材摘要

Sirona Dental CAD/CAM System with InLab Software is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K200191. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sirona Dental CAD/CAM System with InLab Software?

Sirona Dental CAD/CAM System with InLab Software is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Dentsply Sirona. The 510(k) number is K200191.

When did Sirona Dental CAD/CAM System with InLab Software receive FDA 510(k) clearance?

Sirona Dental CAD/CAM System with InLab Software received FDA 510(k) clearance on 2020-08-19, under 510(k) number K200191.

Who is the listed applicant for Sirona Dental CAD/CAM System with InLab Software?

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

What is the FDA product code for Sirona Dental CAD/CAM System with InLab Software?

The FDA product code for Sirona Dental CAD/CAM System with InLab Software is PNP.

其他以 Dentsply Sirona 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：PNP）

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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