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FDA 510(k)

3M Clarity 矫正器（3M Clarity 矫正器-Force，3M Clarity 矫正器-Flex）

K 號：K211190 · 2021-04-23

申請人3M Company, Unitek Orthodontic Products
決定日期2021-04-23
產品代碼NXC
諮詢委員會DE
決定相當於

器材摘要

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company, Unitek Orthodontic Products. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K211190. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)?

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is 3M Company, Unitek Orthodontic Products. The 510(k) number is K211190.

When did 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) receive FDA 510(k) clearance?

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) received FDA 510(k) clearance on 2021-04-23, under 510(k) number K211190.

Who is the listed applicant for 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)?

The FDA 510(k) record lists 3M Company, Unitek Orthodontic Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)?

The FDA product code for 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is NXC.

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

其他以 3M Company, Unitek Orthodontic Products 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。

K2332573M™ Clarity™Aligners with Quick AttachmentsK2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)

相關器械（代碼：NXC）

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。

K260527臉部4D調整器Avinent Implant System S.L.U.K260788斯麥麗歐正畸器Smylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile系統Dror Orthodesign , Ltd.K251454清齊正齊器（SCF-3348）Beame Medical Technology (Shenzhen) LimitedK250739Primeprint直接對齊器Dreve Dentamid GmbH

官方來源

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