FDA 510(k)

ProVactra 3D Prime 配合 VistaSoft

K 號：K181432 · 2018-08-02

決定日期2018-08-02

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

ProVectra 3D Prime with VistaSoft is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K181432. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProVectra 3D Prime with VistaSoft?

ProVectra 3D Prime with VistaSoft is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Durr Dental SE. The 510(k) number is K181432.

When did ProVectra 3D Prime with VistaSoft receive FDA 510(k) clearance?

ProVectra 3D Prime with VistaSoft received FDA 510(k) clearance on 2018-08-02, under 510(k) number K181432.

Who is the listed applicant for ProVectra 3D Prime with VistaSoft?

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

What is the FDA product code for ProVectra 3D Prime with VistaSoft?

The FDA product code for ProVectra 3D Prime with VistaSoft is OAS.

其他以 Durr Dental SE 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。

K250947VistaSoft 4.0 及 VisionX 4.0 K232487Provecta 3D Prime 及 Provecta 3D Prime 頭顱 K230095ScanX Swift 2.0，ScanX Swift View 2.0 K213326視覺X 3.0 K203116感應X K193139ProVecta 3D Prime 複合醫療設備規範文本

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相關器械（代碼：OAS）

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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