FDA 510(k)

注射式根管封閉劑（KP-Root SP）

K 號：K261415 · 2026-06-29

申請人Guilin Kevin Peter Technology Co., Ltd.

決定日期2026-06-29

產品代碼KIF

諮詢委員會DE

決定相當於

器材摘要

Injectable Root Canal Sealer (KP-Root SP) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K261415. 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 Injectable Root Canal Sealer (KP-Root SP)?

Injectable Root Canal Sealer (KP-Root SP) is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. The 510(k) number is K261415.

When did Injectable Root Canal Sealer (KP-Root SP) receive FDA 510(k) clearance?

Injectable Root Canal Sealer (KP-Root SP) received FDA 510(k) clearance on 2026-06-29, under 510(k) number K261415.

Who is the listed applicant for Injectable Root Canal Sealer (KP-Root SP)?

FDA 510(k) 記錄將桂林凱文彼得科技有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Injectable Root Canal Sealer (KP-Root SP)?

The FDA product code for Injectable Root Canal Sealer (KP-Root SP) is KIF.

其他以 Guilin Kevin Peter Technology Co., Ltd. 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。

K261047牙科二極雷射設備（雷射筆）K261695流動性修復材質（KP-Flow LF，KP-Flow MF，KP-Flow HF）K261514鈣氫氧化臨時填充材質（KP-Cal）

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.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation K251465根管修復材質（nRoot BP）Enpuno Biotechnology Co., Ltd.

官方來源

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