FDA 510(k)

Sonendo 填充材料 5C

K 號：K211995 · 2021-08-27

決定日期2021-08-27

產品代碼KIF

諮詢委員會DE

決定相當於

器材摘要

Sonendo Filling Material 5C is the device name listed in this FDA 510(k) record. The listed applicant is Sonendo, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K211995. 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 Sonendo Filling Material 5C?

Sonendo Filling Material 5C is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Sonendo, Inc.. The 510(k) number is K211995.

When did Sonendo Filling Material 5C receive FDA 510(k) clearance?

Sonendo Filling Material 5C received FDA 510(k) clearance on 2021-08-27, under 510(k) number K211995.

Who is the listed applicant for Sonendo Filling Material 5C?

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

What is the FDA product code for Sonendo Filling Material 5C?

The FDA product code for Sonendo Filling Material 5C is KIF.

其他以 Sonendo, Inc. 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。

K203302GentleWave X K190359Sonendo柔波系統 K181922Sonendo 材質 A K160905Sonendo柔波系統 K153157Sonendo柔波系統

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。

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ 預混充填膠NuSmile, Ltd.K261514鈣氫氧化臨時填充材質（KP-Cal）Guilin Kevin Peter Technology Co., Ltd.K261415注射式根管封閉劑（KP-Root SP）Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

官方來源

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