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FDA 510(k)

Cristaline Aligners Z FLX

K 號:K242892 · 2024-12-19

決定日期2024-12-19
產品代碼NXC
諮詢委員會DE
決定相當於

器材摘要

Cristaline Aligners Z FLX is the device name listed in this FDA 510(k) record. The listed applicant is Cristaline Aligners GmbH. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242892. 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 Cristaline Aligners Z FLX?

Cristaline Aligners Z FLX is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Cristaline Aligners GmbH. The 510(k) number is K242892.

When did Cristaline Aligners Z FLX receive FDA 510(k) clearance?

Cristaline Aligners Z FLX received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242892.

Who is the listed applicant for Cristaline Aligners Z FLX?

The FDA 510(k) record lists Cristaline Aligners GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cristaline Aligners Z FLX?

The FDA product code for Cristaline Aligners Z FLX 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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