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FDA 510(k)

牙科高速涡轮手柄，牙科低速涡轮手柄

K 號：K212910 · 2022-11-17

申請人Shenzhen Carejoy Technology Co., Ltd.
決定日期2022-11-17
產品代碼EFB
諮詢委員會DE
決定相當於

器材摘要

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Carejoy Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K212910. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Shenzhen Carejoy Technology Co., Ltd.. The 510(k) number is K212910.

When did Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece receive FDA 510(k) clearance?

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece received FDA 510(k) clearance on 2022-11-17, under 510(k) number K212910.

Who is the listed applicant for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

The FDA 510(k) record lists Shenzhen Carejoy Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

The FDA product code for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is EFB.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：EFB）

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。

K262144DIAMED 手柄；DIAMED 空氣驅動機；DIAMED 空氣驅動機手柄SETAGAYA SEIKI Co., Ltd.K251389高速空氣涡轮手柄Foshan Topmed Dental Co., Ltd.K251388牙科空氣馬達手柄（TM-203B2、TM-203M4、TM-205B2、TM-205M4、TM-IS、TM-ES、TM-SG20、TM-X25、TM-BB、TM-IC、TM-RA41）Foshan Topmed Dental Co., Ltd.K242179Synea Fusion 手術刀片（Intensiv & Profin）W&H Dentalwerk Bürmoos GmbHK240337牙科手持機（型號：J6-126、J6-136、SH11W2、SH11W3、W401LW、W15LW、W142LW、W11L）Guangdong Jinme Medical Technology Co., Ltd.K241074高速空氣涡轮手柄（SCHG01、SCHG03、SCHG18、SCHF19、SCHF22），牙科低速手柄包括直柄和齿轮角度手柄以及空氣引擎（直柄手柄：SCHD05-S、SCHD16-S、SCHD17-S、SCHD24-S、SCHD27-S；齿轮角度手柄：SCHD05-C、SCHD06-C、SCHD16-C、SCHD17-C、SCHD24-C、SCHD27-C、SCHD29-S、SCHB4、SCHB5、SCHB20、SCHB64；空氣引擎：SCHD16-M、SCHD17-M、SCHD24-M、SCHD27-M）Foshan Soco Precision Instrument Co., Ltd.

官方來源

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