FDA 510(k)

Medidenta 高速手持式工具

K 號：K202674 · 2022-12-12

決定日期2022-12-12

產品代碼EFB

諮詢委員會DE

決定相當於

器材摘要

Medidenta High Speed Handpieces is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2022-12-12 under 510(k) number K202674. 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 Medidenta High Speed Handpieces?

Medidenta High Speed Handpieces is a medical device that received FDA 510(k) clearance on 2022-12-12. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K202674.

When did Medidenta High Speed Handpieces receive FDA 510(k) clearance?

Medidenta High Speed Handpieces received FDA 510(k) clearance on 2022-12-12, under 510(k) number K202674.

Who is the listed applicant for Medidenta High Speed Handpieces?

The FDA 510(k) record lists Pac-Dent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medidenta High Speed Handpieces?

The FDA product code for Medidenta High Speed Handpieces is EFB.

其他以 Pac-Dent, Inc. 為申請人之記錄

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K202920OptiComp K202831The iMask 優兒童臉部口罩 K210189Pac-Dent 義齒基底樹脂 K210412Pac-Dent 鈷酸鹽纳米雙組合树脂 K210186PacBond One K201182iMask 一次性外科口罩

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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.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.K251389高速空氣涡轮手柄Foshan Topmed Dental Co., Ltd.K242179Synea Fusion 手術刀片（Intensiv & Profin）W&H Dentalwerk Bürmoos GmbH K240337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.

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