FDA 510(k)

Provecta 3D Prime 及 Provecta 3D Prime 頭顱

K 號：K232487 · 2023-09-14

決定日期2023-09-14

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

Provecta 3D Prime and Provecta 3D Prime Ceph 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 2023-09-14 under 510(k) number K232487. 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 Provecta 3D Prime and Provecta 3D Prime Ceph?

Provecta 3D Prime and Provecta 3D Prime Ceph is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Durr Dental SE. The 510(k) number is K232487.

When did Provecta 3D Prime and Provecta 3D Prime Ceph receive FDA 510(k) clearance?

Provecta 3D Prime and Provecta 3D Prime Ceph received FDA 510(k) clearance on 2023-09-14, under 510(k) number K232487.

Who is the listed applicant for Provecta 3D Prime and Provecta 3D Prime Ceph?

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 Provecta 3D Prime and Provecta 3D Prime Ceph?

The FDA product code for Provecta 3D Prime and Provecta 3D Prime Ceph 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。

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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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