FDA 510(k)

els超低縮水率®複合材料 & els超低縮水率®流體

K 號：K240823 · 2024-06-27

決定日期2024-06-27

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

els extra low shrinkage® composite & els extra low shrinkage® flow is the device name listed in this FDA 510(k) record. The listed applicant is Saremco Dental AG. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K240823. 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 els extra low shrinkage® composite & els extra low shrinkage® flow?

els extra low shrinkage® composite & els extra low shrinkage® flow is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Saremco Dental AG. The 510(k) number is K240823.

When did els extra low shrinkage® composite & els extra low shrinkage® flow receive FDA 510(k) clearance?

els extra low shrinkage® composite & els extra low shrinkage® flow received FDA 510(k) clearance on 2024-06-27, under 510(k) number K240823.

Who is the listed applicant for els extra low shrinkage® composite & els extra low shrinkage® flow?

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

What is the FDA product code for els extra low shrinkage® composite & els extra low shrinkage® flow?

The FDA product code for els extra low shrinkage® composite & els extra low shrinkage® flow is EBF.

其他以 Saremco Dental AG 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。

K252151els unibond K232050saremco 印刷 BRIDGETEC K213343Saremco Print CROWNTEC

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。

K262982Core·it雙用式醫療設備規範文本Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流動性修復材質（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus 填充劑；Tetric plus 流動劑Ivoclar Vivadent, Inc.K262228超越大量填充濃縮複合材料Ultradent Products, Inc.K261246SRGC-06GC America, Inc.

官方來源

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