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FDA 510(k)

Signum複合流；Signum通用粘合劑；Signum金屬粘合劑；Signum複合；Signum矩陣；Signum液體；Signum cre-active

K 號：K240660 · 2024-09-17

申請人Kulzer, LLC
決定日期2024-09-17
產品代碼EBF
諮詢委員會DE
決定相當於

器材摘要

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240660. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Kulzer, LLC. The 510(k) number is K240660.

When did Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active receive FDA 510(k) clearance?

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240660.

Who is the listed applicant for Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

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

What is the FDA product code for Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active?

The FDA product code for Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active is EBF.

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。

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其他以 Kulzer, LLC 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：EBF）

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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