FDA 510(k)

優質加強型預防牙科空氣機器

K 號：K170261 · 2017-10-19

決定日期2017-10-19

產品代碼EFB

諮詢委員會DE

決定相當於

器材摘要

Premium Plus Prophy Air Motor is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plus International Limited. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K170261. 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 Premium Plus Prophy Air Motor?

Premium Plus Prophy Air Motor is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Premium Plus International Limited. The 510(k) number is K170261.

When did Premium Plus Prophy Air Motor receive FDA 510(k) clearance?

Premium Plus Prophy Air Motor received FDA 510(k) clearance on 2017-10-19, under 510(k) number K170261.

Who is the listed applicant for Premium Plus Prophy Air Motor?

The FDA 510(k) record lists Premium Plus International Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premium Plus Prophy Air Motor?

The FDA product code for Premium Plus Prophy Air Motor is EFB.

其他以 Premium Plus International Limited 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。

K163447優級加值一次性防護袖套 K153514優質加強版 C01/C02 LED 紫外線固化燈

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 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.

官方來源

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