FDA 510(k)

ENDOSOLV

K 號：K172839 · 2018-02-13

決定日期2018-02-13

產品代碼KIF

諮詢委員會DE

決定相當於

器材摘要

ENDOSOLV is the device name listed in this FDA 510(k) record. The listed applicant is Septodont. It received FDA 510(k) clearance on 2018-02-13 under 510(k) number K172839. 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 ENDOSOLV?

ENDOSOLV is a medical device that received FDA 510(k) clearance on 2018-02-13. The listed applicant is Septodont. The 510(k) number is K172839.

When did ENDOSOLV receive FDA 510(k) clearance?

ENDOSOLV received FDA 510(k) clearance on 2018-02-13, under 510(k) number K172839.

Who is the listed applicant for ENDOSOLV?

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 ENDOSOLV?

The FDA product code for ENDOSOLV 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。

K212283生物根流0.5g，生物根流2g K211799Biodentine XP 500, Biodentine XP 200

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。