FDA 510(k)

不鏽鋼外科工具組

K 號：K251614 · 2026-02-06

決定日期2026-02-06

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Stainless Steel Surgical Kits is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K251614. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stainless Steel Surgical Kits?

Stainless Steel Surgical Kits is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K251614.

When did Stainless Steel Surgical Kits receive FDA 510(k) clearance?

Stainless Steel Surgical Kits received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251614.

Who is the listed applicant for Stainless Steel Surgical Kits?

FDA 510(k) 記錄將 Dentsply Sirona, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Stainless Steel Surgical Kits?

The FDA product code for Stainless Steel Surgical Kits is KCT.

其他以 Dentsply Sirona, 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。

K261935外科及義肢托盤 K260722SureSmile Aligner (ASSY500020)K253565SureSmile 軟體 K253009DS核心偵測 K250771Primescan 2 K251811馬達與頂端模組（MaAM）

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相關器械（代碼：KCT）

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。

K253988LiteSet 盤子Nobel Biocare AB K261935外科及義肢托盤Dentsply Sirona, Inc.K253187SteriBest® 過濾消毒托盤系統Mastel Surgical K252854SteriTite容器系統搭配MediTray產品Case Medical, Inc.K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ 快速連接針筒系統托盤；PUREVUE™ 快速連接針筒系統蓋DePuy Mitek, Inc.

官方來源

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