FDA 510(k)

MEM 清晰正畸系統

K 號：K242637 · 2025-05-21

決定日期2025-05-21

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

MEM Clear Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Mem Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K242637. 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 MEM Clear Aligner System?

MEM Clear Aligner System is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Mem Dental Technology Co., Ltd.. The 510(k) number is K242637.

When did MEM Clear Aligner System receive FDA 510(k) clearance?

MEM Clear Aligner System received FDA 510(k) clearance on 2025-05-21, under 510(k) number K242637.

Who is the listed applicant for MEM Clear Aligner System?

The FDA 510(k) record lists Mem Dental Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEM Clear Aligner System?

The FDA product code for MEM Clear Aligner System is NXC.

其他以 Mem Dental Technology Co., Ltd. 為申請人之記錄

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K180952陶瓷托架

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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