FDA 510(k)

生物科技牙科套件

K 號：K212068 · 2021-11-08

決定日期2021-11-08

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

Biotech Dental Kits is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Dental, Sas. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K212068. 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 Biotech Dental Kits?

Biotech Dental Kits is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Biotech Dental, Sas. The 510(k) number is K212068.

When did Biotech Dental Kits receive FDA 510(k) clearance?

Biotech Dental Kits received FDA 510(k) clearance on 2021-11-08, under 510(k) number K212068.

Who is the listed applicant for Biotech Dental Kits?

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

What is the FDA product code for Biotech Dental Kits?

The FDA product code for Biotech Dental Kits is KCT.

其他以 Biotech Dental, Sas 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。

K213997Kontact 齿科植體系統 K210220Kontact 齿科植體系統

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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