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FDA 510(k)

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K 號:K222604 · 2023-04-21

申請人Dentona AG
決定日期2023-04-21
產品代碼MQC
決定相當於

器材摘要

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S is the device name listed in this FDA 510(k) record. The listed applicant is Dentona AG. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K222604. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S?

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Dentona AG. The 510(k) number is K222604.

When did dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S receive FDA 510(k) clearance?

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S received FDA 510(k) clearance on 2023-04-21, under 510(k) number K222604.

Who is the listed applicant for dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S?

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

What is the FDA product code for dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S?

The FDA product code for dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S is MQC.

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。

相關器械(代碼:MQC)

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。

官方來源

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