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FDA 510(k)

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)

K 號：K231464 · 2023-05-22

申請人3M Company, Unitek Orthodontic Products
決定日期2023-05-22
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 2023-05-22 under 510(k) number K231464. 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 2023-05-22. The listed applicant is 3M Company, Unitek Orthodontic Products. The 510(k) number is K231464.

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 2023-05-22, under 510(k) number K231464.

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 AttachmentsK2111903M Clarity 矫正器（3M Clarity 矫正器-Force，3M Clarity 矫正器-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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