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FDA 510(k)

3M Clear Tray 矫正器

K 號:K163689 · 2017-01-27

決定日期2017-01-27
產品代碼NXC
諮詢委員會DE
決定相當於

器材摘要

3M Clear Tray Aligner is the device name listed in this FDA 510(k) record. The listed applicant is 3M Unitek Corporation. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K163689. 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 Clear Tray Aligner?

3M Clear Tray Aligner is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is 3M Unitek Corporation. The 510(k) number is K163689.

When did 3M Clear Tray Aligner receive FDA 510(k) clearance?

3M Clear Tray Aligner received FDA 510(k) clearance on 2017-01-27, under 510(k) number K163689.

Who is the listed applicant for 3M Clear Tray Aligner?

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

What is the FDA product code for 3M Clear Tray Aligner?

The FDA product code for 3M Clear Tray Aligner is NXC.

相關臨床試驗

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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。

官方來源

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