FDA 510(k)

Biodentine XP 500, Biodentine XP 200

K 號：K211799 · 2021-08-10

決定日期2021-08-10

產品代碼KIF

諮詢委員會DE

決定相當於

器材摘要

Biodentine XP 500, Biodentine XP 200 is the device name listed in this FDA 510(k) record. The listed applicant is Septodont. It received FDA 510(k) clearance on 2021-08-10 under 510(k) number K211799. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biodentine XP 500, Biodentine XP 200?

Biodentine XP 500, Biodentine XP 200 is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is Septodont. The 510(k) number is K211799.

When did Biodentine XP 500, Biodentine XP 200 receive FDA 510(k) clearance?

Biodentine XP 500, Biodentine XP 200 received FDA 510(k) clearance on 2021-08-10, under 510(k) number K211799.

Who is the listed applicant for Biodentine XP 500, Biodentine XP 200?

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

What is the FDA product code for Biodentine XP 500, Biodentine XP 200?

The FDA product code for Biodentine XP 500, Biodentine XP 200 is KIF.

其他以 Septodont 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：KIF）

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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