FDA 510(k)

諾貝爾齊哥馬 PureSet™ 盤

K 號：K231219 · 2023-06-27

決定日期2023-06-27

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

NobelZygoma PureSet™ Tray is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K231219. 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 NobelZygoma PureSet™ Tray?

NobelZygoma PureSet™ Tray is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K231219.

When did NobelZygoma PureSet™ Tray receive FDA 510(k) clearance?

NobelZygoma PureSet™ Tray received FDA 510(k) clearance on 2023-06-27, under 510(k) number K231219.

Who is the listed applicant for NobelZygoma PureSet™ Tray?

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

What is the FDA product code for NobelZygoma PureSet™ Tray?

The FDA product code for NobelZygoma PureSet™ Tray is KCT.

其他以 Nobel Biocare Services 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。

K220339美學牙根 Nobel Biocare N1 K220048諾貝爾普雷塞拉 ZrO2 N1 基座 K211109N1 TiUltra TCC 偽裝系統 K212932諾貝爾生物醫學 NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

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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