FDA 510(k)

Invisalign System with Mandibular Advancement Feature

K 號：K181739 · 2018-10-26

決定日期2018-10-26

產品代碼NXC

諮詢委員會DE

決定Substantially Equivalent

器材摘要

Invisalign System with Mandibular Advancement Feature is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2018-10-26 under 510(k) number K181739. 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 Invisalign System with Mandibular Advancement Feature?

Invisalign System with Mandibular Advancement Feature is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Align Technology, Inc.. The 510(k) number is K181739.

When did Invisalign System with Mandibular Advancement Feature receive FDA 510(k) clearance?

Invisalign System with Mandibular Advancement Feature received FDA 510(k) clearance on 2018-10-26, under 510(k) number K181739.

Who is the listed applicant for Invisalign System with Mandibular Advancement Feature?

The FDA 510(k) record lists Align Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Invisalign System with Mandibular Advancement Feature?

The FDA product code for Invisalign System with Mandibular Advancement Feature is NXC.

其他以 Align Technology, Inc. 為申請人之記錄

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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。

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官方來源

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